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"GSK4528287 is a drug being developed to treat like inflammatory bowel diseases like Crohns disease and ulcerative colitis. This study is the first time that GSK4528287 will be given to humans. The study will test single doses of GSK4528287 to check for side effects, measure blood levels, and understand how it works in the body. The study will start with a small dose, and the dose will be increased for each new group of participants."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose 1 | Experimental | Participants will be administered Dose 1 of GSK4528287. |
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| Cohort 2: Dose 2 | Experimental | Participants will be administered Dose 2 of GSK4528287. |
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| Cohort 3: Dose 3 | Experimental | Participants will be administered Dose 3 of GSK4528287. |
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| Cohort 4: Dose 4 | Experimental | Participants will be administered Dose 4 of GSK4528287. |
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| Cohort 5: Dose 5 | Experimental | Participants will be administered Dose 5 of GSK4528287. |
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| Cohort 6: Dose 6 | Experimental | Participants will be administered Dose 6 of GSK4528287. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK4528287 | Drug | GSK4528287 will be administered. |
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| 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 Day 351 (End of follow up period) |
| 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. | Up to Day 351 (End of follow up period) |
| Number of Participants with Clinically Significant Changes in Laboratory Values | Number of participants with clinically significant changes in laboratory values (hematology, chemistry, urinalysis, and virology) will be assessed. | Up to Day 351 (End of follow up period) |
| 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 Day 351 (End of follow up period) |
| Number of Participants with Clinically Significant Changes in Telemetry | Number of participants with clinically significant changes in telemetry will be assessed. | On Day 1 |
| Number of Participants with Clinically Significant Changes in 12 lead Electrocardiogram (ECG) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under concentration-time curve (AUC) of GSK4528287 | Blood sample will be collected to evaluate plasma concentration of AUC of GSK4528287. | Up to Day 337 |
| Maximum concentration (Cmax) of GSK4528287 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | CB2 0GG | United Kingdom |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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 terminated asset(s) 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 single centre, double-blind study.
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The investigators will be blinded not knowing which study intervention each participant will be assigned to and this will be maintained throughout the course of the study.
| Placebo | Placebo Comparator | Participants will receive Placebo. |
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| Placebo | Drug | Placebo will be administered. |
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Number of participants with clinically significant changes in 12 lead ECG will be assessed.
| Up to Day 351 (End of follow up period) |
Blood sample will be collected to evaluate plasma concentration of Cmax of GSK4528287.
| Up to Day 337 |
| Time to maximum concentration (Tmax) of GSK4528287 | Blood sample will be collected to evaluate plasma concentration of Tmax of GSK4528287. | Up to Day 337 |
| Apparent terminal phase half life (T-half) of GSK4528287 | Blood sample will be collected to evaluate plasma concentration of T-half of GSK4528287. | Up to Day 337 |
| Clearance (CL) of GSK4528287 | Blood sample will be collected to evaluate plasma concentration of CL of GSK4528287. | Up to Day 337 |
| Bioavailability of GSK4528287 | Blood sample will be collected to evaluate plasma concentration of SC bioavailability of GSK4528287. | Up to Day 337 |
| Number of Participants with Confirmed Positive and Negative anti-GSK4528287 Antibodies | Number of participants with confirmed positive and negative anti-GSK4528287 Antibodies will be assessed. | Up to Day 211 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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