Study identifier:D7000C00007
ClinicalTrials.gov identifier:NCT05932641
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults
COVID-19, SARS-CoV-2
Phase 1
Yes
-
All
24
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
AZD3152 is being evaluated for administration to prevent COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD3152 as well as relevant data on the PK, PD (as the neutralising responses against SARS-CoV-2) profile and the generation of ADA to AZD3152.
This is a Phase I, randomised, double-blind, placebo controlled study evaluating the safety, tolerability, PK and PD of AZD3152 in healthy Japanese adult participants, 18 to 55 years of age. Approximately 24 healthy participants will be randomised at up to 2 study sites.
Location
Location
Fukuoka-shi, Japan, 812-0025
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 |
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