Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577597
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Safety Tolerability and Blood Sampling of GSK3923868 Administered Via Dry Powder Inhaler to Healthy Participants of Chinese Japanese and European Ancestry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Safety Tolerability and Pharmacokinetics of Single Doses of GSK3923868 Administered Via Dry Powder Inhaler to Healthy Participants of Chinese Japanese and European Ancestry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This study is designed to understand how the drug GSK3923868 works in the bodies of healthy people from Japanese Chinese and European ancestries This is important to meet the rules for including these groups in future worldwide studies The study is carefully planned to reduce differences that might come from comparing results across different studies and locations making it easier to compare results between these ethnic groups The main goal is to check if GSK3923868 is safe and easy to tolerate when given as a single inhaled dose to healthy people from these three ancestries The study also wants to see how the drug moves in the blood after a single inhaled dose in these groups On the first day of the study participants will be randomly chosen to receive either a single dose of GSK3923868 or a placebo The aim is to have enough people take part so that 10 healthy people from each ancestry group a total of 30 people can successfully finish the study Should a participant withdraw from the study before completion the GSK Medical Monitor and the investigator may select a replacement The replacement participant will be assigned the same treatment as the original participant
Detailed Description:
None
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