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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-525073-37 | Other Identifier | EU CT Number |
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This is a first time in Asia (FTIA) study of GSK4771261 in healthy participants of Chinese, Japanese, and White/European ancestry. The study will test whether GSK4771261 is safe, well-tolerated, how it is processed in the body, and whether it triggers an immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK4771261 | Experimental | Healthy participants of Chinese, Japanese, or White/European ancestry will receive GSK4771261. |
|
| Placebo | Experimental | Healthy participants of Chinese, Japanese, or White/European ancestry will receive Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK4771261 | Drug | GSK4771261 will be administered. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs), Injection Site Reactions, and Serious AEs (SAEs) | Up to Week 13 (End of Study) | |
| Number of Participants with Clinically Significant Changes from Baseline in Vital Signs | Up to Week 13 (End of Study) | |
| Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Values | Up to Week 13 (End of Study) | |
| Number of Participants with Clinically Significant Changes from Baseline in 12-Lead Electrocardiogram (ECG) | Up to Week 13 (End of Study) | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) | Up to Week 13 | |
| Area under the serum concentration-time curve extrapolated to infinite time (AUC[0-inf]) | Up to Week 13 | |
| Maximum observed serum concentration (Cmax) | Up to Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with pre-existing Anti-Drug Antibodies (ADAs) | Up to Week 13 (End of Study) | |
| Number of Participants with treatment-emergent ADAs | Up to Week 13 (End of Study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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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://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.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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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Drug |
Placebo will be administered. |
|
| D052801 | Male Urogenital Diseases |