Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06681181 | A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants | PHASE1 | ACTIVE NOT_RECRUITING | 48 | — | — | Nov 18, 2024 | Feb 25, 2027 | Apr 6, 2026 | 1 | United Kingdom |
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 \>...