This study aims to assess the ethnic sensitivity of GSK3862995B in terms of safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) in healthy participants of Chinese, Japanese, and European ancestry to enable the inclusion of Chinese and Japanese participants in future global studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
GSK3862995B will be administered.
Matching placebo will be administered.
GSK Investigational Site
Cypress, California, United States
GSK Investigational Site
Las Vegas, Nevada, United States
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.
Time frame: Up to Week 44 (End of follow up visit)
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 inpatient 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, or abnormal pregnancy outcomes (such as, spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy).
Time frame: Up to Week 44 (End of follow up visit)
Number of Participants with Clinically Significant Changes in Clinical Laboratory Values
Number of Participants with clinically significant changes in clinical laboratory values (hematology, chemistry and urinalysis) will be assessed.
Time frame: Up to Week 36
Number of Participants with Clinically Significant Changes in Vital Signs
Number of Participants with clinically significant changes in vital signs will be assessed.
Time frame: Up to Week 36
Number of Participants with Clinically Significant Changes in 12-lead (Electrocardiogram (ECG)
Number of Participants with clinically significant changes in 12-lead ECG will be assessed.
Time frame: Up to Week 36
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) of GSK3862995B
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
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Time frame: Up to Week 36
Maximum Observed Concentration (Cmax) of GSK3862995B
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
Time frame: Up to Week 36