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The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic [PK] study) in healthy adults. The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK5784283 Test Formulation | Experimental |
| |
| GSK5784283 Reference Formulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK5784283 | Drug | GSK5784283 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples | Pre-dose and up to 253 days post dose | |
| Area Under the Curve from Zero up to 253 Days [AUC(0-253 d)] of GSK5784283 Serum Samples | Pre-dose and up to 253 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious AEs and Adverse Event of Special Interest (AESI) | Up to 253 days | |
| Number of Participants with Clinically Significant Change from Baseline in Laboratory Assessments, Vital Signs and Electrocardiogram (ECG) Values |
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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://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.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 |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Baseline and up to 253 days |
| Proportion of Participants with Anti-drug Antibody (ADA) Incidence, ADA Titre Assessment and Neutralizing Antibody (NAb) Incidence Against GSK5784283 | Up to 253 days |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |