GSK3862995B
DrugGSK3862995B will be administered.
NCT Number: NCT06979518
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Cypress, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GSK3862995B will be administered.
Matching placebo will be administered.
Time frame: Up to Week 44 (End of follow up visit)
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)
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 36
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 will be assessed.
Time frame: Up to Week 36
Number of Participants with clinically significant changes in 12-lead ECG will be assessed.
Time frame: Up to Week 36
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
Time frame: Up to Week 36
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
GlaxoSmithKline
Industry
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK3862995B Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and European Ancestry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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