A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults with Asthma

Study identifier:MI-CP197

ClinicalTrials.gov identifier:NCT00783289

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple-dose Subcutaneous Administration of MEDI-563, a Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, in Adults with Asthma

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 14 Nov 2008

Primary Completion Date: 17 Nov 2009

Study Completion Date: 17 Nov 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2019 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female subjects
- Age 18 through 80 years at screening
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Previously documented diagnosis of asthma of more than or equal to (>=) 1 year duration, based on episodic symptoms of airflow obstruction; post-bronchodilator reversibility of airflow obstruction >=12 percent (%) (at screening or documented within 1 year prior to randomization); or proof of a positive response to a methacholine challenge (documented within 1 year prior to randomization) as represented by a provoking concentration of methacholine to cause a 20% fall in forced expiratory volume in 1 second (FEV1); (PC20) less than (<) 8 milligram per milliliter (mg/mL)
- Weight of >=45 kilogram (kg) but less than or equal to (<=) 135 kg (>=100 pounds [lb] but <=300 lb)
- Able to produce spirometry readings that meet American Thoracic Society (ATS)/European Respiratory Society (ERS) standards
- Screening pre-bronchodilator FEV1 >=60%
- Women of childbearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must use 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) for 14 days prior to the first dose of the investigational product on Study Day 0, and must agree to continue using such precautions through Study Day 161. Cessation of birth control after this point should be discussed with a responsible physician
- Men, unless surgically sterile, must likewise use 2 effective methods of birth control (for example, condom with spermicide) and must agree to continue using such contraceptive precautions through End of Study/Study Day 161
- Ability to complete the study period, including follow-up period until Study Day 161 as required by protocol

Exclusion Criteria

- Previously received benralizumab (MEDI-563)
- History of allergy or reaction to any component of the investigational product formulation
- History of allergy or reaction to any other marketed or experimental monoclonal antibody therapies, intravenous gammaglobulin (IVIG), or blood products
- Receipt of any investigational drug therapy within 30 days prior to randomization into the study or any biologic(s) within 5 half-lives of the agent prior to randomization into the study
- Treatment with an oral or systemic burst of corticosteroids within 4 weeks prior to randomization into the study
- Use of any chronic systemic immunosuppressive drugs, including oral corticosteroids within 4 weeks prior to randomization into the study
- Current use of any oral or ophthalmic beta-adrenergic antagonist (for example, propranolol), must have been stopped 2 weeks prior to randomization into the study
- Current allergy vaccination (immunotherapy)
- History of anaphylaxis
- Lung disease other than persistent asthma (for example, chronic bronchitis, cystic fibrosis, chronic obstructive pulmonary disease [COPD], tuberculosis [TB])
- Acute illnesses or evidence of significant active infection, such as fever >=38.0 degrees Celsius [C] (>=100.5 degrees Fahrenheit [F]) at screening and up through time of the first dose of the investigational product
- History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or an untreated parasitic infection within 1 month of randomization
- Pregnancy (women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of the investigational product)
- Lactating woman
- Infection with human immunodeficiency virus (HIV)-1, HIV-2, or hepatitis A, B, or C virus
- History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >= 1 year prior to randomization into the study
- History of cigarette smoking >=10 pack years
- History of alcohol abuse or drug abuse that required treatment <1 year prior to randomization into the study
- Elective surgery planned during the study period
- Evidence of any systemic disease or any finding upon physical examination, laboratory abnormality, chest x-ray (CXR), or electrocardiogram (ECG) that, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the study results
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or first degree family members of such individuals (that is, parents, siblings, or children)

Location

Research Site

Upland, PA, United States

Location

Research Site

Colarado Springs, CO, United States

Location

Research Site

Encinitas, CA, United States

Location

Research Site

Los Angeles, CA, United States

Location

Allergy Associates Research Center

Portland, OR, United States, 97213

Location

Research Site

Wheaton, MD, United States

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.	Other: Placebo Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
Experimental: Benralizumab 25 mg Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.	Biological/Vaccine: Benralizumab 25 mg Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56. Other Name: MEDI-563
Experimental: Benralizumab 100 mg Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.	Biological/Vaccine: Benralizumab 100 mg Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56. Other Name: MEDI-563
Experimental: Benralizumab 200 mg Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.	Biological/Vaccine: Benralizumab 200 mg Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56. Other Name: MEDI-563

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Placebo	Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Participant Flow: Overall Study

	Placebo	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg
STARTED	6	7	6	6
COMPLETED	6	6	6	6
NOT COMPLETED	0	1	0	0
Protocol Violation	0	1	0	0

Baseline Characteristics

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

Intent-to-treat (ITT) population included all participants randomized into the study.

Reporting Groups

	Description
Placebo	Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Baseline Measures

	Placebo	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg	Total
Number of Participants [units: Participants]	6	7	6	6	25
Age Continuous [units: years] Mean ± Standard Deviation	45.7 ± 11.2	50.4 ± 12.3	45.5 ± 13.4	40.2 ± 12.5	45.6 ± 12.2
Sex: Female, Male [units: ]
Female	3	4	4	3	14
Male	3	3	2	3	11

Outcome Measures

1. Primary Outcome Measure: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 0 to Day 161 ]

Measure Type	Primary
Measure Name	Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Measure Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 161 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame	Day 0 to Day 161
Safety Issue?	Yes

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 population included all participants who received at least 1 dose of the investigational product.

Reporting Groups

	Description
Placebo	Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Measured Values

	Placebo	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg
Number of Participants Analyzed [units:participants]	6	7	6	6
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [units: participants]
TEAEs	3	4	4	4
TESAEs	0	0	0	0

No statistical analysis provided for Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

2. Secondary Outcome Measure: Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab [ Time Frame: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 ]

Measure Type	Secondary
Measure Name	Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab
Measure Description
Time Frame	Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Safety Issue?	No

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 population included all participants who received at least 1 dose of the investigational product. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

Reporting Groups

	Description
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Measured Values

	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg
Number of Participants Analyzed [units:participants]	6	6	6
Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab [units: days] Median (Full Range)	7.00 (7.00 to 28.00)	7.00 (1.00 to 7.00)	7.00 (7.00 to 7.00)

No statistical analysis provided for Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab

3. Secondary Outcome Measure: Maximum Observed Serum Concentration (Cmax) for Benralizumab [ Time Frame: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 ]

Measure Type	Secondary
Measure Name	Maximum Observed Serum Concentration (Cmax) for Benralizumab
Measure Description
Time Frame	Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Safety Issue?	No

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 population included all participants who received at least 1 dose of the investigational product. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

Reporting Groups

	Description
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Measured Values

	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg
Number of Participants Analyzed [units:participants]	6	6	6
Maximum Observed Serum Concentration (Cmax) for Benralizumab [units: microgram per milliliter (mcg/mL)] Mean (Standard Deviation)	1.152 (0.615)	4.127 (1.775)	15.637 (8.062)

No statistical analysis provided for Maximum Observed Serum Concentration (Cmax) for Benralizumab

4. Secondary Outcome Measure: Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab [ Time Frame: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 ]

Measure Type	Secondary
Measure Name	Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab
Measure Description	Area under the serum concentration-time curve from time-zero extrapolated to infinity postdose.
Time Frame	Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Safety Issue?	No

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 population included all participants who received at least 1 dose of the investigational product. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

Reporting Groups

	Description
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Measured Values

	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg
Number of Participants Analyzed [units:participants]	4	4	4
Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab [units: microgram*day per milliliter] Mean (Standard Deviation)	118.335 (69.640)	405.868 (205.856)	1157.013 (86.444)

No statistical analysis provided for Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab

5. Secondary Outcome Measure: Terminal Phase Elimination Half-Life (t1/2) for Benralizumab [ Time Frame: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 ]

Measure Type	Secondary
Measure Name	Terminal Phase Elimination Half-Life (t1/2) for Benralizumab
Measure Description	Terminal phase elimination half-life (t1/2) is the time measured for the serum concentration to decrease by one half.
Time Frame	Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Safety Issue?	No

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 population included all participants who received at least 1 dose of the investigational product. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

Reporting Groups

	Description
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Measured Values

	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg
Number of Participants Analyzed [units:participants]	4	4	4
Terminal Phase Elimination Half-Life (t1/2) for Benralizumab [units: days] Mean (Standard Deviation)	17.163 (2.368)	18.610 (3.905)	18.315 (3.484)

No statistical analysis provided for Terminal Phase Elimination Half-Life (t1/2) for Benralizumab

6. Secondary Outcome Measure: Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at any Visit [ Time Frame: Day 0, 28, 56, 84, 112, and 161 ]

Measure Type	Secondary
Measure Name	Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at any Visit
Measure Description
Time Frame	Day 0, 28, 56, 84, 112, and 161
Safety Issue?	Yes

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 population included all participants who received at least 1 dose of the investigational product.

Reporting Groups

	Description
Placebo	Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Measured Values

	Placebo	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg
Number of Participants Analyzed [units:participants]	6	7	6	6
Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at any Visit [units: participants]	0	1	1	2

No statistical analysis provided for Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at any Visit

Serious Adverse Events

Time Frame	Day 0 to Day 161
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Serious Adverse Events

	Placebo	Benralizumab 25 mg	Benralizumab 100 mg	Benralizumab 200 mg
Total, serious adverse events
# participants affected / at risk	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)

Other Adverse Events

Time Frame	Day 0 to Day 161
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Placebo	Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Other Adverse Events

Placebo

Benralizumab 25 mg

Benralizumab 100 mg

Benralizumab 200 mg

Total, other (not including serious) adverse events

# participants affected / at risk

3/6 (50.00%)

4/7 (57.14%)

4/6 (66.67%)

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/7 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Infections and infestations

Bronchitis bacterial¹,^†

# participants affected / at risk

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Infections and infestations

Gastrointestinal viral infection¹,^†

# participants affected / at risk

0/6 (0.00%)

0/7 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Infections and infestations

Oral candidiasis¹,^†

# participants affected / at risk

2/6 (33.33%)

0/7 (0.00%)

0/6 (0.00%)

# events

Infections and infestations

Oral herpes¹,^†

# participants affected / at risk

0/6 (0.00%)

0/7 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Infections and infestations

Postoperative wound infection¹,^†

# participants affected / at risk

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Infections and infestations

Respiratory tract infection viral¹,^†

# participants affected / at risk

0/6 (0.00%)

0/7 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Infections and infestations

Sinobronchitis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/7 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

1/6 (16.67%)

0/7 (0.00%)

1/6 (16.67%)

2/6 (33.33%)

# events

Infections and infestations

Viral infection¹,^†

# participants affected / at risk

1/6 (16.67%)

0/7 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Injury, poisoning and procedural complications

Contusion¹,^†

# participants affected / at risk

1/6 (16.67%)

0/7 (0.00%)

0/6 (0.00%)

# events

Injury, poisoning and procedural complications

Muscle strain¹,^†

# participants affected / at risk

1/6 (16.67%)

0/7 (0.00%)

0/6 (0.00%)

# events

Injury, poisoning and procedural complications

Post-traumatic pain¹,^†

# participants affected / at risk

1/6 (16.67%)

0/7 (0.00%)

0/6 (0.00%)

# events

Injury, poisoning and procedural complications

Procedural pain¹,^†

# participants affected / at risk

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Investigations

Blood creatine phosphokinase increased¹,^†

# participants affected / at risk

1/6 (16.67%)

1/7 (14.29%)

0/6 (0.00%)

# events

Investigations

Blood urea increased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Investigations

Troponin i increased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Investigations

White blood cell count decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/7 (14.29%)

1/6 (16.67%)

0/6 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/7 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign breast neoplasm¹,^†

# participants affected / at risk

0/6 (0.00%)

0/7 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

0/6 (0.00%)

0/7 (0.00%)

2/6 (33.33%)

0/6 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

0/6 (0.00%)

2/7 (28.57%)

0/6 (0.00%)

1/6 (16.67%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Sinus congestion¹,^†

# participants affected / at risk

1/6 (16.67%)

0/7 (0.00%)

0/6 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash papular¹,^†

# participants affected / at risk

1/6 (16.67%)

0/7 (0.00%)

0/6 (0.00%)

# events

Skin and subcutaneous tissue disorders

Urticaria¹,^†

# participants affected / at risk

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 12.1

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: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.

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
No text entered.

Results Point of Contact

Name/Title:	Rene van der Merwe, MBChB/Senior Director, Clinical Development
Organization:	MedImmune, LLC.
Phone	301-398-0000
E-mail:	[email protected]

Documents available

Attachments tab: MI-CP197 Redacted Protocol_22_Jul_2015
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

David Gossage

MedImmune LLC

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Allergy Associates Research Center

Research Site

Attachments tab: MI-CP197 Redacted Protocol_22_Jul_2015

Trial Results Summaries