NCT07222254

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to Healthy Japanese Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.

Detailed description

This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study in healthy Japanese participants to investigate 2 dose levels of AZD0292. Participants will be randomized to receive either AZD0292 or placebo, proceeding with sentinel cohorts. The study will comprise: * A Screening Period of maximum 28 days. * A Treatment Period during which participants will be resident at the site from the day before study intervention administration (Day -1) until at least 24 h post-EOI with study intervention; and discharged on Day 2. * A Follow-up Period from Day 3 to Day 16. * An extended Follow-up Period from Day 17 to Day 161.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD0292	Single dose of AZD0292 will be administered as an IV infusion.
DRUG	Placebo	Single dose of placebo will be administered as an IV infusion.

Timeline

• Start date: 2025-12-12
• Primary completion: 2026-07-20
• Completion: 2026-07-20
• First posted: 2025-10-29
• Last updated: 2026-03-05

Locations

1 site across 1 country: Japan