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GSK4528287 · 1 trial · 1 indication
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.
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.
Number of participants with clinically significant changes in laboratory values (hematology, chemistry, urinalysis, and virology) will be assessed.
Number of participants with clinically significant changes in vital signs will be assessed.
Number of participants with clinically significant changes in telemetry will be assessed.
Number of participants with clinically significant changes in 12 lead ECG will be assessed.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose 1 | EXPERIMENTAL | Participants will be administered Dose 1 of GSK4528287. |
| Cohort 2: Dose 2 | EXPERIMENTAL | Participants will be administered Dose 2 of GSK4528287. |
| Cohort 3: Dose 3 | EXPERIMENTAL | Participants will be administered Dose 3 of GSK4528287. |
| Cohort 4: Dose 4 | EXPERIMENTAL | Participants will be administered Dose 4 of GSK4528287. |
| Cohort 5: Dose 5 | EXPERIMENTAL | Participants will be administered Dose 5 of GSK4528287. |
| Cohort 6: Dose 6 | EXPERIMENTAL | Participants will be administered Dose 6 of GSK4528287. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo. |
| Name | Type | Description |
|---|---|---|
| GSK4528287 | DRUG | GSK4528287 will be administered. |
| Placebo | DRUG | Placebo will be administered. |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * White blood cell greater than or equal to (\>=) lower limit of normal (LLN), including both lymphocyte counts \>...
GSK4528287 is an investigational small molecule being developed for ulcerative colitis, a form of inflammatory bowel disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential to treat this gastrointestinal condition.
GSK4528287 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for ulcerative colitis.
GSK4528287 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The Phase 1 trial is designed to assess safety, tolerability, pharmacokinetics, and target engagement in healthy participants.
GSK4528287 is being studied in a Phase 1 first-time-in-human trial with the identifier NCT06681181. This randomized, double-blind, placebo-controlled study is evaluating the drug in 48 healthy participants in the United Kingdom. The trial is currently active but not recruiting participants.
The specific molecular target of GSK4528287 has not been disclosed in available information. As a small molecule being developed for ulcerative colitis, it is believed to interact with pathways involved in the inflammatory process, but the exact mechanism of action remains under investigation in clinical trials.