Study identifier:D7060C00001
ClinicalTrials.gov identifier:NCT04198558
EudraCT identifier:2019-002128-33
CTIS identifier:N/A
A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers
Chronic Pain
Phase 1
Yes
MEDI0618, Placebo
All
64
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2023 by AstraZeneca
AstraZeneca
-
This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer participants.
This is a randomised, double-blind, placebo-controlled study of the safety, tolerability, and pharmacokinetics of single ascending doses of MEDI0618 in healthy male and female volunteers. This study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of MEDI0618 or placebo by intravenous (IV) administration, 1 cohort will receive MEDI0618 or placebo by subcutaneous (SC) administration. All participants will undergo scheduled safety, tolerability, pharmacokinetics, and immunogenicity assessments while in the clinical unit and as outpatients to the end of the follow-up period.
Location
Location
Berlin, Germany, 10117
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 9: MEDI0618 Dose Level 9 Participants will receive a single SC injection of MEDI0618 Dose level 9 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Placebo Comparator: Cohort 9: Placebo Participants will receive a single SC injection of placebo matched to MEDI0618 Dose level 9 on Day 1. | Drug: Placebo Participants will receive placebo matched to MEDI0618 on Day 1 as stated in arm description. |
Experimental: Cohort 8: MEDI0618 Dose Level 8 Participants will receive a single IV infusion of MEDI0618 Dose level 8 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Experimental: Cohort 7: MEDI0618 Dose Level 7 Participants will receive a single IV infusion of MEDI0618 Dose level 7 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Experimental: Cohort 6: MEDI0618 Dose Level 6 Participants will receive a single IV infusion of MEDI0618 Dose level 6 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Experimental: Cohort 5: MEDI0618 Dose Level 5 Participants will receive a single IV infusion of MEDI0618 Dose level 5 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Experimental: Cohort 4: MEDI0618 Dose Level 4 Participants will receive a single IV infusion of MEDI0618 Dose level 4 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Experimental: Cohort 3: MEDI0618 Dose Level 3 Participants will receive a single IV infusion of MEDI0618 Dose level 3 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Experimental: Cohort 2: MEDI0618 Dose Level 2 Participants will receive a single IV infusion of MEDI0618 Dose level 2 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Experimental: Cohort 1: MEDI0618 Dose Level 1 Participants will receive a single IV infusion of MEDI0618 Dose level 1 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
Placebo Comparator: Cohorts 1-8: Placebo Participants will receive a single dose of placebo matched to MEDI0618 Dose levels 1-8 by IV infusion on Day 1. | Drug: Placebo Participants will receive placebo matched to MEDI0618 on Day 1 as stated in arm description. |
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