Safety, Tolerability and Blood Sampling of GSK3923868 Administered Via Dry Powder Inhaler to Healthy Participants of Chinese, Japanese and European Ancestry
NCT Number: NCT06577597
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Respiratory Tract Infections
Interventions: DRUG: GSK3923868|DRUG: Placebo
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2024-10-23
Locations: GSK Investigational Site, Harrow, HA1 3UJ, United Kingdom

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.

Primary Outcome Measures: Number of Participants with Adverse events (AE), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention, Up to Day 14 (End of follow up)|Number of Participants with Serious Adverse events (SAE), An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; abnormal pregnancy outcome; or is a suspected transmission of any infectious agent via an authorized medicinal product., Up to Day 14 (End of follow up)|Number of Participants with Clinically Significant Changes in Laboratory Values, Clinically significant changes in laboratory values (Clinical Chemistry, Haematology and Coagulation Clinical Chemistry, Haematology, and Coagulation) will be assessed., Up to Day 14 (End of follow up)|Number of Participants with Clinically Significant Changes in Laboratory values, Clinically significant changes in Laboratory values (Urinalysis) will be assessed., Up to Day 14 (End of follow up)|Number of Participants with Clinically Significant Changes in Vital signs, Clinically significant changes in Vital signs (systolic and diastolic blood pressure, heart rate, respiration rate, pulse oximetry and oral temperature) will be assessed., Up to Day 14 (End of follow up)|Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG), Clinically significant changes in 12-lead ECG will be assessed., Up to Day 14 (End of follow up)|Number of Participants with Clinically Significant Changes in Spirometry Measurements, Number of participants with clinically significant changes in Spirometry measurements., On Day 14 (End of follow up)|Area Under the Plasma GSK3923868 Concentration Versus Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-t]) of GSK3923868, Blood samples will be collected at the specified timepoints for the pharmacokinetics (PK) assessments., Up to Day 4|Area under the Plasma GSK3923868 Concentration versus Time Curve from Time zero to Infinity (AUC[0-inf]) of GSK3923868, Blood samples will be collected at the specified timepoints for the PK assessments., Up to Day 4|Maximum Observed GSK3923868 Plasma Concentration (Cmax) of GSK3923868, Blood samples will be collected at the specified timepoints for the PK assessments., Up to Day 4|Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3923868, Blood samples will be collected at the specified timepoints for the PK assessments., Up to Day 4|Terminal Half-life (T1/2) of GSK3923868, Blood samples will be collected at the specified timepoints for the PK assessments., Up to Day 4