Study of AZD3152 Intramuscular Injection or Intravenous Infusion in Healthy Japanese Adult Participants
NCT05932641 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2024-12-27
Summary
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.
Conditions
- COVID-19, SARS-CoV-2
Interventions
- BIOLOGICAL
-
AZD3152 (Cohort 1)
Single dose of AZD3152 300 mg IM on Visit 2 Day 1
- BIOLOGICAL
-
Placebo (Cohort 1)
Single dose of Placebo IM on Visit 2 Day 1
- BIOLOGICAL
-
AZD3152 (Cohort 2)
Single dose of AZD3152 600 mg IM on Visit 2 Day 1
- BIOLOGICAL
-
Placebo (Cohort 2)
Single dose of Placebo IM on Visit 2 Day 1
- BIOLOGICAL
-
AZD3152 (Cohort 3)
Single dose of AZD3152 1200 mg IV on Visit 2 Day 1
- BIOLOGICAL
-
Placebo (Cohort 3)
Single dose of Placebo IM on Visit 2 Day 1
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-31
- Primary Completion
- 2024-12-05
- Completion
- 2024-12-05
- FDA Drug
- Yes
Countries
- Japan
Study Locations
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