NCT05932641

Study of AZD3152 Intramuscular Injection or Intravenous Infusion in Healthy Japanese Adult Participants

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• COVID-19, SARS-CoV-2

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2023-07-06
• Last updated: 2024-12-27

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study