Study of AZD3152 intramuscular injection or intravenous infusion in Healthy Japanese Adult Participants
Study identifier:D7000C00007
ClinicalTrials.gov identifier:NCT05932641
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults
Medical condition
COVID-19, SARS-CoV-2
Phase
Phase 1
Healthy volunteers
Yes
Study drug
-
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 31 Jul 2023
Estimated Primary Completion Date: 19 Dec 2024
Estimated Study Completion Date: 19 Dec 2024
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verification:
Verified 01 Aug 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection | Biological/Vaccine: AZD3152 (Cohort 1) Single dose of AZD3152 300 mg IM on Visit 2 Day 1 |
| Placebo Comparator: Cohort 1 - Placebo IM direct anterolateral thigh injection | Biological/Vaccine: Placebo (Cohort 1) Single dose of Placebo IM on Visit 2 Day 1 |
| Experimental: Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection | Biological/Vaccine: AZD3152 (Cohort 2) Single dose of AZD3152 600 mg IM on Visit 2 Day 1 |
| Placebo Comparator: Cohort 2 - Placebo direct anterolateral thigh injection | Biological/Vaccine: Placebo (Cohort 2) Single dose of Placebo IM on Visit 2 Day 1 |
| Experimental: Cohort 3 - AZD3152 1200 mg IV administration | Biological/Vaccine: AZD3152 (Cohort 3) Single dose of AZD3152 1200 mg IV on Visit 2 Day 1 |
| Placebo Comparator: Cohort 3 - Placebo IV administration | Biological/Vaccine: Placebo (Cohort 3) Single dose of Placebo IM on Visit 2 Day 1 |
