Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519968
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
A Study to Investigate the Safety Tolerability and Pharmacokinetics of Inhaled AZD4604 in Healthy Japanese and Chinese Participants
Sponsor:
None
Organization:
None
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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None