Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT06519968
Brief 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
Study:
NCT06519968
Study Brief:
Protocol Section:
NCT06519968