Study to investigate AZD4604 following single and multiple doses in Japanese and Chinese volunteers
Research type
Research Study
Full title
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
IRAS ID
1009745
Contact name
Gunilla Wall
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
The trial is a single centre, single blind, placebo-controlled trial in up to 56 healthy Japanese and Chinese male and female (including females of childbearing potential) participants between the ages of 18 and 55 years.
The medicine to be tested in this trial is a compound called AZD4604 which is being developed as an inhaled therapy for the treatment of asthma.
The main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated after administering it as single and multiple inhaled doses to healthy Japanese (Part 1) and Chinese (Part 2) participants. The clinical trial will also investigate how the clinical trial medicine is taken up, metabolised (chemically broken down), distributed through the body and excreted (removed from the body).
The trial will comprise of two parts: A single dose part (Part 1a and 2a) and a multiple dose part (Part 1b and 2b).
- Screening period of a maximum 28 days
- Part 1a and 2a: In-house period: Day -1 to Day 7
- Part 1b and 2b: In-house period: Day -1 to Day 13
- The follow up visit and last day of the study is the Discharge day either Day 7 or Day 13
Participants will receive single doses of the trial medication once (Part 1a and 2a) or multiple doses of the trial medication twice a day (Part 1b and 2b) from Day 1-6 and a single dose on Day 7.
The duration of the study will be up to 5 weeks for participants receiving single doses and up to 6 weeks for participants receiving multiple doses.This not a first-in-human trial as the trial medication has been given to humans before in clinical trials.
REC name
North East - York Research Ethics Committee
REC reference
24/NE/0062
Date of REC Opinion
11 Jun 2024
REC opinion
Further Information Favourable Opinion