NCT06519968

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 in Healthy Japanese and Chinese Participants.

A Single-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 Following Single Ascending and Multiple Doses in Healthy Japanese and Chinese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4604 when administered as single or multiple inhaled doses to healthy Japanese and Chinese participants.

Detailed description

This study will comprise of two parts: Part 1 and Part 2 Part 1 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Japanese participants. Part 1a will include three single ascending dose (SAD) cohorts and Part 1b will include one multiple dose cohort. Part 2 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Chinese participants. Part 2a will include two SAD cohort and Part 2b will include one multiple dose cohort. Part 1a and Part 2a will comprise of: 1. A Screening Visit within 28 days before dosing. 2. A treatment period (Day 1 to Day 7) 3. A final assessment on Day 7 Part 1b and Part 2b will comprise of: 1. A Screening Visit within 28 days before dosing. 2. A treatment period (Day 1 to Day 13) 3. A final assessment on Day 13

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD4604	AZD4604 will be administered as Dry Powder Inhalation (DPI).
DRUG	Placebo	Placebo will be administered as DPI.

Timeline

• Start date: 2024-07-15
• Primary completion: 2024-12-27
• Completion: 2024-12-27
• First posted: 2024-07-25
• Last updated: 2025-11-17

Locations

1 site across 1 country: United Kingdom