A study to evaluate the safety and tolerability of AZD7442 in Healthy Chinese Adults

Study identifier:D8850C00007

ClinicalTrials.gov identifier:NCT05437289

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in Healthy Chinese Adults

Medical condition

Coronavirus disease 2019 (COVID-19), Healthy Volunteer

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD7442 IM, Placebo IM, AZD7442 IV, Placebo IV

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 09 Oct 2021

Primary Completion Date: 27 Nov 2021

Study Completion Date: 16 Jan 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Nov 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Shanghai, China, 201107

Location

Research Site

Guangzhou, China, 510515

Arms	Assigned Interventions
Experimental: 300 mg AZD7442 IM Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.	Drug: AZD7442 IM In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections. Other Name: AZD7442
Placebo Comparator: 300mg placebo IM Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.	Drug: Placebo IM In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. Other Name: Placebo
Experimental: 600 mg AZD7442 IM Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.	Drug: AZD7442 IM In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections. Other Name: AZD7442
Placebo Comparator: 600mg placebo IM Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.	Drug: Placebo IM In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. Other Name: Placebo
Experimental: 300 mg AZD7442 IV co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.	Drug: AZD7442 IV In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. Other Name: AZD7442
Placebo Comparator: 300mg placebo IV co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.	Drug: Placebo IV In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. Other Name: Placebo
Experimental: 600 mg AZD7442 IV co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.	Drug: AZD7442 IV In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. Other Name: Evusheld
Placebo Comparator: 600mg placebo IV co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.	Drug: Placebo IV In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. Other Name: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject enrolled in China 09Oct2021

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Participant Flow: Overall Study

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
STARTED	12	12	12	13	11
COMPLETED	12	12	12	13	11
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Baseline Measures

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total	Total
Number of Participants [units: Participants]	12	12	12	13	11	60
Age Continuous [units: years] Mean ± Standard Deviation	32.9 ± 8.9	32.5 ± 6.0	31.8 ± 5.9	30.9 ± 5.8	31.0 ± 5.3	31.8 ± 6.3
Sex: Female, Male [units: participants]
Female	3	3	2	4	2	14
Male	9	9	10	9	9	46
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0	0	0	0
Asian	12	12	12	13	11	60
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0
White	0	0	0	0	0	0
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Incidence of adverse events (AEs) [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Incidence of adverse events (AEs)
Measure Description	To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Incidence of adverse events (AEs) [units: Participants]	9	12	12	12	9

No statistical analysis provided for Incidence of adverse events (AEs)

2. Primary Outcome Measure: Incidence of serious adverse events (SAEs) [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Incidence of serious adverse events (SAEs)
Measure Description	To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Incidence of serious adverse events (SAEs) [units: Participants]	0	1	0	1	0

No statistical analysis provided for Incidence of serious adverse events (SAEs)

3. Primary Outcome Measure: Incidence of adverse event of special interests (AESIs) [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Incidence of adverse event of special interests (AESIs)
Measure Description	To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Incidence of adverse event of special interests (AESIs) [units: Participants]	0	1	0	0	0

No statistical analysis provided for Incidence of adverse event of special interests (AESIs)

4. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of white blood cell (WBC) count, red blood cell (RBC) count.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]
WBC - Baseline to minimum post baseline: Normal to Low	0	1	0	1	0
WBC - Baseline to maximum post baseline: Normal to High	1	0	1	1	0
RBC - Baseline to minimum post baseline: Normal to Low	0	1	0	1	0
RBC - Baseline to minimum post baseline: High to Normal	0	1	0	0	0
RBC - Baseline to minimum post baseline: High to High	0	1	0	0	0
RBC - Baseline to maximum post baseline: Normal to High	0	0	0	0	1
RBC - Baseline to maximum post baseline: High to Normal	0	1	0	0	0
RBC - Baseline to maximum post baseline: High to High	0	1	0	0	0

No statistical analysis provided for Number of participants with abnormal laboratory test results

5. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), calcium, phosphate, glucose, c-reactive protein (CRP).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]
Sodium - Baseline to minimum post baseline: Normal to Low	2	3	5	6	2
Sodium - Baseline to minimum post baseline: Low to Low	0	1	0	1	0
Sodium - Baseline to minimum post baseline: Low to Normal	0	0	1	0	0
Sodium - Baseline to maximum post baseline: Low to Normal	0	1	1	1	0
Potassium - Baseline to minimum post baseline: Normal to Low	0	0	3	1	2
Potassium - Baseline to minimum post baseline: Low to Low	1	0	0	0	0
Potassium - Baseline to maximum post baseline: Low to Normal	1	0	0	0	0
Urea - Baseline to minimum post baseline: Low to Low	1	1	1	1	0
Urea - Baseline to minimum post baseline: Low to Normal	1	1	0	0	0
Urea - Baseline to minimum post baseline: Normal to Low	3	3	4	3	1
Urea - Baseline to minimum post baseline: High to Normal	0	0	1	0	0
Urea - Baseline to maximum post baseline: Low to Normal	2	2	1	1	0
Urea - Baseline to maximum post baseline: High to Normal	0	0	1	0	0
Calcium - Baseline to minimum post baseline: Normal to Low	0	0	0	1	0
Calcium - Baseline to minimum post baseline: High to Normal	0	1	4	0	1
Calcium - Baseline to maximum post baseline: Normal to High	0	0	1	4	2
Calcium - Baseline to maximum post baseline: High to Normal	0	1	1	0	0
Calcium - Baseline to maximum post baseline: High to High	0	0	3	0	1
Phosphate - Baseline to minimum post baseline: Low to Normal	1	1	0	0	0
Phosphate - Baseline to minimum post baseline: Normal to Low	1	0	1	3	0
Phosphate - Baseline to maximum post baseline: Low to Normal	1	1	0	0	0
Phosphate - Baseline to maximum post baseline: Normal to High	1	2	0	0	2
Glucose - Baseline to minimum post baseline: Low to Normal	0	0	1	0	0
Glucose - Baseline to maximum post baseline: Low to Normal	0	0	1	0	0
Glucose - Baseline to maximum post baseline: Normal to High	5	2	2	1	1
CRP - Baseline to minimum post baseline: High to Normal	0	0	0	1	0
CRP - Baseline to maximum post baseline: Normal to High	1	0	2	2	0
CRP - Baseline to maximum post baseline: High to Normal	0	0	0	1	0

No statistical analysis provided for Number of participants with abnormal laboratory test results

6. Primary Outcome Measure: Number of participants with abnormal Coagulation test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal Coagulation test results
Measure Description	Measurement of prothrombin time, activated partial thrombin time (aPTT).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal Coagulation test results [units: Participants]
Prothrombin Time - Baseline to minimum post baseline: Low to Low	0	1	0	1	1
Prothrombin Time - Baseline to minimum post baseline: Normal to Low	1	0	3	2	1
Prothrombin Time - Baseline to maximum post baseline: Low to Low	0	0	0	1	0
Prothrombin Time - Baseline to maximum post baseline: Low to Normal	0	1	0	0	1
Prothrombin Time - Baseline to maximum post baseline: Normal to High	0	0	1	0	1
aPTT - Baseline to minimum post baseline: Normal to Low	0	1	0	0	0
aPTT - Baseline to minimum post baseline: High to Normal	0	1	0	0	0
aPTT - Baseline to minimum post baseline: High to High	0	0	1	0	0
aPTT - Baseline to maximum post baseline: High to High	0	1	1	0	0

No statistical analysis provided for Number of participants with abnormal Coagulation test results

7. Primary Outcome Measure: Number of participants with abnormal urinalysis [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal urinalysis
Measure Description	Measurement of glucose, protein, and blood.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal urinalysis [units: Participants]
Glucose - Baseline to maximum post baseline: +- to +-	0	1	0	0	0
Protein - Baseline to maximum post baseline: - to +-	0	3	0	0	0
Protein - Baseline to maximum post baseline: - to +	0	0	0	1	0
Protein - Baseline to maximum post baseline: +- to +-	0	0	0	0	1
Blood - Baseline to maximum post baseline: - to +-	1	0	0	0	2
Blood - Baseline to maximum post baseline: - to +	2	2	3	0	0
Blood - Baseline to maximum post baseline: - to ++	0	0	0	1	0
Blood - Baseline to maximum post baseline: - to +++	1	2	0	1	0
Blood - Baseline to maximum post baseline: +- to -	0	0	1	0	0
Blood - Baseline to maximum post baseline: +- to +-	1	0	1	0	1
Blood - Baseline to maximum post baseline: +- to +	0	1	0	1	0
Blood - Baseline to maximum post baseline: +- to +++	0	0	0	1	0
Blood - Baseline to maximum post baseline: + to +	0	0	0	1	0
Blood - Baseline to maximum post baseline: + to ++	1	0	0	0	0
Blood - Baseline to maximum post baseline: +++ to +++	0	0	0	0	1

No statistical analysis provided for Number of participants with abnormal urinalysis

8. Primary Outcome Measure: Number of participants with abnormal ECG readings [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal ECG readings
Measure Description	Results for heart rate, PR interval, QRS duration, QT interval, QTcF interval, and RR interval will be analyzed. Overall ECG evaluation is displayed.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal ECG readings [units: Participants]
ECG Overall - Baseline to worst post baseline: Normal to Abnormal,NCS	6	3	1	2	3
ECG Overall - Baseline to worst post baseline: Normal to Abnormal,CS	0	0	0	1	0
ECG Overall - Baseline to worst post baseline: Abnormal,NCS to Normal	0	1	1	3	1
ECG Overall - Baseline to worst post baseline: Abnormal,NCS to Abnormal,NCS	5	5	4	3	4
ECG Overall - Baseline to worst post baseline: Abnormal,NCS to Abnormal,CS	0	0	1	0	1

No statistical analysis provided for Number of participants with abnormal ECG readings

9. Primary Outcome Measure: Number of participants with abnormal vital signs [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal vital signs
Measure Description	Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal vital signs [units: Participants]
Systolic Blood Pressure - Baseline to minimum post baseline: Normal to Low	0	0	1	0	0
Systolic Blood Pressure - Baseline to maximum post baseline: Normal to High	0	0	1	0	0
Diastolic Blood Pressure - Baseline to minimum post baseline: Low to Low	0	1	0	0	0
Diastolic Blood Pressure - Baseline to minimum post baseline: Low to Normal	0	0	0	0	1
Diastolic Blood Pressure - Baseline to minimum post baseline: Normal to Low	4	4	3	3	2
Diastolic Blood Pressure - Baseline to maximum post baseline: Low to Normal	0	1	0	0	1
Diastolic Blood Pressure - Baseline to maximum post baseline: Normal to High	0	0	0	1	0

No statistical analysis provided for Number of participants with abnormal vital signs

10. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]
Neutrophils - Baseline to minimum post baseline: Normal to Low	0	1	0	1	0
Neutrophils - Baseline to maximum post baseline: Normal to High	1	2	2	1	0
Lymphocytes - Baseline to minimum post baseline: Low to Normal	0	0	1	1	0
Lymphocytes - Baseline to minimum post baseline: Normal to Low	1	2	0	0	0
Lymphocytes - Baseline to minimum post baseline: High to Normal	1	0	1	0	0
Lymphocytes - Baseline to maximum post baseline: Low to Normal	0	0	1	1	0
Lymphocytes - Baseline to maximum post baseline: High to Normal	0	0	1	0	0
Lymphocytes - Baseline to maximum post baseline: High to High	1	0	0	0	0
Monocytes - Baseline to minimum post baseline: High to Normal	1	0	0	1	0
Monocytes - Baseline to minimum post baseline: High to High	0	0	1	0	0
Monocytes - Baseline to maximum post baseline: Normal to High	0	0	2	1	0
Monocytes - Baseline to maximum post baseline: High to High	1	0	1	1	1
Eosinophils - Baseline to minimum post baseline: Low to Normal	0	0	0	1	0
Eosinophils - Baseline to minimum post baseline: Normal to Low	0	3	0	1	0
Eosinophils - Baseline to maximum post baseline: Low to Normal	0	0	0	1	0
Eosinophils - Baseline to maximum post baseline: Normal to High	0	0	1	0	0
Platelets - Baseline to minimum post baseline: High to Normal	0	1	0	0	0
Platelets - Baseline to maximum post baseline: Normal to High	0	0	1	1	0
Platelets - Baseline to maximum post baseline: High to Normal	0	1	0	0	0
Reticulocytes - Baseline to minimum post baseline: Normal to Low	1	0	0	0	0
Reticulocytes - Baseline to minimum post baseline: Normal to High	0	0	1	0	0
Reticulocytes - Baseline to minimum post baseline: High to Normal	0	0	1	0	0
Reticulocytes - Baseline to maximum post baseline: Normal to High	0	0	3	2	1
Reticulocytes - Baseline to maximum post baseline: High to High	0	0	1	0	0

No statistical analysis provided for Number of participants with abnormal laboratory test results

11. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of haemoglobin (Hb).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	11	13
Number of participants with abnormal laboratory test results [units: Participants]
Hb - Baseline to minimum post baseline: Normal to Low	0	2	1	0	0
Hb - Baseline to minimum post baseline: High to Normal	0	0	0	0	1
Hb - Baseline to maximum post baseline: High to Normal	0	0	0	0	1

No statistical analysis provided for Number of participants with abnormal laboratory test results

12. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of haematocrit (HCT).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]
HCT - Baseline to minimum post baseline: Normal to Low	1	3	2	0	0
HCT - Baseline to minimum post baseline: High to Normal	0	1	0	0	0
HCT - Baseline to maximum post baseline: Normal to High	0	0	1	0	0
HCT - Baseline to maximum post baseline: High to High	0	1	0	0	0

No statistical analysis provided for Number of participants with abnormal laboratory test results

13. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of mean corpuscular volume (MCV).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]
MCV - Baseline to minimum post baseline: Low to Low	0	1	0	0	0
MCV - Baseline to minimum post baseline: Low to Normal	0	0	0	1	0
MCV - Baseline to minimum post baseline: Normal to Low	1	0	0	0	0
MCV - Baseline to maximum post baseline: Low to Normal	0	1	0	1	0

No statistical analysis provided for Number of participants with abnormal laboratory test results

14. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of mean corpuscular haemoglobin (MCH).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]	1	0	0	0	0

No statistical analysis provided for Number of participants with abnormal laboratory test results

15. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), creatine kinase.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]
ALP - Baseline to minimum post baseline: Low to Low	1	0	0	0	0
ALP - Baseline to minimum post baseline: High to Normal	0	1	2	0	0
ALP - Baseline to minimum post baseline: High to High	1	0	0	0	0
ALP - Baseline to maximum post baseline: Low to Low	1	0	0	0	0
ALP - Baseline to maximum post baseline: Normal to High	0	0	0	1	0
ALP - Baseline to maximum post baseline: High to High	1	1	2	0	0
ALT - Baseline to minimum post baseline: Low to Low	1	0	1	0	0
ALT - Baseline to minimum post baseline: Low to Normal	0	1	0	0	0
ALT - Baseline to minimum post baseline: Normal to Low	1	1	4	1	0
ALT - Baseline to maximum post baseline: Low to Normal	1	1	1	0	0
ALT - Baseline to maximum post baseline: Normal to High	1	1	0	1	3
AST - Baseline to minimum post baseline: Low to Low	3	2	1	0	1
AST - Baseline to minimum post baseline: Low to Normal	0	0	1	0	0
AST - Baseline to minimum post baseline: Normal to Low	4	5	2	1	2
AST - Baseline to maximum post baseline: Low to Low	0	0	1	0	0
AST - Baseline to maximum post baseline: Low to Normal	3	2	0	0	1
AST - Baseline to maximum post baseline: Low to High	0	0	1	0	0
AST - Baseline to maximum post baseline: Normal to Low	0	0	0	1	0
AST - Baseline to maximum post baseline: Normal to High	1	1	0	1	2
GGT - Baseline to minimum post baseline: Low to Low	1	0	0	0	1
GGT - Baseline to minimum post baseline: Normal to Low	0	1	0	0	0
GGT - Baseline to minimum post baseline: High to Normal	0	0	0	1	0
GGT - Baseline to maximum post baseline: Low to Low	1	0	0	0	1
GGT - Baseline to maximum post baseline: Normal to High	0	2	0	0	4
GGT - Baseline to maximum post baseline: High to Normal	0	0	0	1	0
Creatine Kinase - Baseline to minimum post baseline: Normal to Low	0	2	0	0	0
Creatine Kinase - Baseline to minimum post baseline: High to Normal	0	0	1	1	1
Creatine Kinase - Baseline to maximum post baseline: Normal to High	1	1	0	4	0
Creatine Kinase - Baseline to maximum post baseline: High to High	0	0	1	1	1

No statistical analysis provided for Number of participants with abnormal laboratory test results

16. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of creatinine, total bilirubin, conjugated bilirubin.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]
Creatinine - Baseline to maximum post baseline: Normal to High	1	1	2	1	3
Total Bilirubin - Baseline to minimum post baseline: High to Normal	1	0	0	0	0
Total Bilirubin - Baseline to maximum post baseline: Normal to High	0	1	2	0	2
Total Bilirubin - Baseline to maximum post baseline: High to Normal	1	0	0	0	0
Conjugated Bilirubin - Baseline to minimum post baseline: High to Normal	1	0	0	0	1
Conjugated Bilirubin - Baseline to maximum post baseline: Normal to High	0	1	1	1	1
Conjugated Bilirubin - Baseline to maximum post baseline: High to Normal	1	0	0	0	0
Conjugated Bilirubin - Baseline to maximum post baseline: High to High	0	0	0	0	1

No statistical analysis provided for Number of participants with abnormal laboratory test results

17. Primary Outcome Measure: Number of participants with abnormal laboratory test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal laboratory test results
Measure Description	Measurement of albumin.
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal laboratory test results [units: Participants]
Albumin - Baseline to minimum post baseline: Normal to Low	0	0	3	4	0
Albumin - Baseline to minimum post baseline: High to Normal	0	1	0	0	0
Albumin - Baseline to maximum post baseline: High to Normal	0	1	0	0	0

No statistical analysis provided for Number of participants with abnormal laboratory test results

18. Primary Outcome Measure: Number of participants with abnormal Coagulation test results [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal Coagulation test results
Measure Description	Measurement of international normalised ratio (INR).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal Coagulation test results [units: Participants]
INR - Baseline to minimum post baseline: Low to Low	0	3	0	1	2
INR - Baseline to minimum post baseline: Low to Normal	1	0	0	0	0
INR - Baseline to minimum post baseline: Normal to Low	3	3	1	1	1
INR - Baseline to maximum post baseline: High to High	0	1	1	0	0

No statistical analysis provided for Number of participants with abnormal Coagulation test results

19. Primary Outcome Measure: Number of participants with abnormal vital signs [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal vital signs
Measure Description	Measurement of pulse rate (beats per minute), respiratory rate (breaths per minute).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal vital signs [units: Participants]
Pulse Rate - Baseline to minimum post baseline: Low to Low	1	2	0	0	2
Pulse Rate - Baseline to minimum post baseline: Low to Normal	0	1	0	0	0
Pulse Rate - Baseline to minimum post baseline: Normal to Low	7	3	7	6	7
Pulse Rate - Baseline to minimum post baseline: High to Normal	0	0	1	0	0
Pulse Rate - Baseline to maximum post baseline: Low to Normal	1	3	0	0	2
Pulse Rate - Baseline to maximum post baseline: Normal to High	0	0	1	2	0
Pulse Rate - Baseline to maximum post baseline: High to High	0	0	1	0	0

No statistical analysis provided for Number of participants with abnormal vital signs

20. Primary Outcome Measure: Number of participants with abnormal vital signs [ Time Frame: From day 1 to approximately 15 months after administration (through Day 451). ]

Measure Type	Primary
Measure Name	Number of participants with abnormal vital signs
Measure Description	Measurement of body temperature (in degree Celsius).
Time Frame	From day 1 to approximately 15 months after administration (through Day 451).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Measured Values

	300 mg AZD7442 IM	600 mg AZD7442 IM	300 mg AZD7442 IV	600 mg AZD7442 IV	Placebo Total
Number of Participants Analyzed [units:participants]	12	12	12	13	11
Number of participants with abnormal vital signs [units: Participants]	0	0	0	0	0

No statistical analysis provided for Number of participants with abnormal vital signs

Serious Adverse Events

Time Frame	Non-serious AEs and SAEs will be recorded from the time of signature of the ICF through the last participant contact.
Additional Description	No text entered.

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Serious Adverse Events

300 mg AZD7442 IM

600 mg AZD7442 IM

300 mg AZD7442 IV

600 mg AZD7442 IV

Placebo Total

Total, serious adverse events

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

1/13 (7.69%)

0/11 (0.00%)

Infections and infestations

Appendicitis^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

0/13 (0.00%)

0/11 (0.00%)

Gastrointestinal disorders

Inguinal hernia^†

# participants affected / at risk

0/12 (0.00%)

1/13 (7.69%)

0/11 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary,

Other Adverse Events

Time Frame	Non-serious AEs and SAEs will be recorded from the time of signature of the ICF through the last participant contact.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
300 mg AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
600 mg AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo Total	All placebo arms

Other Adverse Events

300 mg AZD7442 IM

600 mg AZD7442 IM

300 mg AZD7442 IV

600 mg AZD7442 IV

Placebo Total

Total, other (not including serious) adverse events

# participants affected / at risk

8/12 (66.67%)

12/12 (100.00%)

11/12 (91.67%)

12/13 (92.31%)

8/11 (72.73%)

Infections and infestations

COVID-19^†

# participants affected / at risk

5/12 (41.67%)

6/12 (50.00%)

8/13 (61.54%)

3/11 (27.27%)

Infections and infestations

Upper respiratory tract infection^†

# participants affected / at risk

3/12 (25.00%)

3/13 (23.08%)

3/11 (27.27%)

Infections and infestations

Suspected COVID-19^†

# participants affected / at risk

0/12 (0.00%)

2/12 (16.67%)

0/13 (0.00%)

0/11 (0.00%)

Nervous system disorders

Headache^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

3/13 (23.08%)

1/11 (9.09%)

Respiratory, thoracic and mediastinal disorders

Cough^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

2/13 (15.38%)

1/11 (9.09%)

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea^†

# participants affected / at risk

0/12 (0.00%)

3/12 (25.00%)

1/13 (7.69%)

1/11 (9.09%)

Respiratory, thoracic and mediastinal disorders

Epistaxis^†

# participants affected / at risk

0/12 (0.00%)

2/13 (15.38%)

0/11 (0.00%)

Respiratory, thoracic and mediastinal disorders

Productive cough^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

1/13 (7.69%)

0/11 (0.00%)

Gastrointestinal disorders

Diarrhoea^†

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

1/12 (8.33%)

1/13 (7.69%)

0/11 (0.00%)

Gastrointestinal disorders

Abdominal pain upper^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

1/13 (7.69%)

0/11 (0.00%)

Skin and subcutaneous tissue disorders

Urticaria^†

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

1/12 (8.33%)

0/13 (0.00%)

0/11 (0.00%)

Musculoskeletal and connective tissue disorders

Back pain^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

1/13 (7.69%)

0/11 (0.00%)

Renal and urinary disorders

Nephrolithiasis^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

1/13 (7.69%)

0/11 (0.00%)

General disorders

Fatigue^†

# participants affected / at risk

2/12 (16.67%)

1/13 (7.69%)

1/11 (9.09%)

Investigations

Blood creatinine increased^†

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

2/12 (16.67%)

1/13 (7.69%)

2/11 (18.18%)

Investigations

Lymphocyte percentage decreased^†

# participants affected / at risk

0/12 (0.00%)

4/12 (33.33%)

0/12 (0.00%)

0/13 (0.00%)

0/11 (0.00%)

Investigations

Neutrophil count increased^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

2/12 (16.67%)

1/13 (7.69%)

0/11 (0.00%)

Investigations

Alanine aminotransferase increased^†

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

1/13 (7.69%)

1/11 (9.09%)

Investigations

Neutrophil percentage increased^†

# participants affected / at risk

0/12 (0.00%)

3/12 (25.00%)

0/12 (0.00%)

0/13 (0.00%)

0/11 (0.00%)

Investigations

White blood cells urine positive^†

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

1/13 (7.69%)

0/11 (0.00%)

Investigations

Blood glucose increased^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

1/13 (7.69%)

0/11 (0.00%)

Investigations

C-reactive protein increased^†

# participants affected / at risk

0/12 (0.00%)

2/13 (15.38%)

0/11 (0.00%)

Investigations

Neutrophil count decreased^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

1/13 (7.69%)

0/11 (0.00%)

Investigations

Urine ketone body present^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

1/13 (7.69%)

0/11 (0.00%)

Investigations

White blood cell count increased^†

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

1/13 (7.69%)

0/11 (0.00%)

Infections and infestations

Appendicitis^†

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

0/13 (0.00%)

0/11 (0.00%)

Investigations

Aspartate aminotransferase increased^†

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/13 (0.00%)

1/11 (9.09%)

Investigations

Blood creatine phosphokinase increased^†

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

0/13 (0.00%)

1/11 (9.09%)

†	Events were collected by systematic assessment
1	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Disclosure is prohibited without providing advance notice to AstraZeneca and opportunity to object.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	Jessie Zhou
Organization:	Hangzhou Tigermed Consulting Co., Ltd
Phone	86 17612109356
E-mail:	[email protected]

Documents available

D8850C00007 Clinical Study Report synopsis Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

D8850C00007 Clinical Study Report synopsis Redacted

Trial Results Summaries