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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
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.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
Yes
GSK Investigational Site
Middlesex, United Kingdom
Start Date
September 2, 2024
Primary Completion Date
November 1, 2024
Completion Date
November 1, 2024
Last Updated
December 10, 2024
30
ACTUAL participants
GSK3923868
DRUG
Placebo
DRUG
Lead Sponsor
GlaxoSmithKline
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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