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Safety, Tolerability and Blood Sampling of GSK3923868 Administered Via Dry Powder Inhaler to Healthy Participants of Chinese, Japanese and European Ancestry

NCT06577597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-10

No results posted yet for this study

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.

Conditions

  • Respiratory Tract Infections

Interventions

DRUG

GSK3923868

Participants will receive single dose of GSK3923868.

DRUG

Placebo

Participants will receive single dose of Placebo.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06577597 on ClinicalTrials.gov