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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3862995B | Experimental | Participants of Chinese, Japanese, or European ancestries will receive GSK3862995B. |
|
| Placebo | Experimental | Participants of Chinese, Japanese, or European ancestries will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3862995B | Drug | GSK3862995B will be administered. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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). | 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. | 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. | 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. | Up to Week 36 |
| Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) of GSK3862995B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cypress | California | 90630 | United States | ||
| GSK Investigational Site |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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This is a randomized, placebo-controlled, double-blind study
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This is a double-blind study where participants Care provider (site staff) and investigator will remain blinded throughout the study.
| Drug |
Matching placebo will be administered. |
|
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B. |
| Up to Week 36 |
| Maximum Observed Concentration (Cmax) of GSK3862995B | Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B. | Up to Week 36 |
| Las Vegas |
| Nevada |
| 89113 |
| United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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