Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-02 @ 12:13 PM
Study NCT ID:
NCT06519968
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 in Healthy Japanese and Chinese Participants.
Sponsor:
AstraZeneca
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: