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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07600450 | A Study of GSK4771261 in Healthy Participants Aged 25 to 55 Years of Age Inclusive | PHASE1 | NOT YET_RECRUITING | 30 | — | — | May 15, 2026 | Sep 22, 2026 | May 20, 2026 | - | — |
| NCT06734234 | A Study to Evaluate the Safety, Tolerability, and Effects on Blood and Urine Markers of Single Ascending Dose of GSK4771261 in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease | PHASE1 | RECRUITING | 84 | — | — | Dec 11, 2024 | Sep 4, 2026 | Aug 7, 2025 | 14 | Belgium, Canada +4 |
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 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; abnormal pregnancy outcome (for example, spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy); is a suspected transmission of any infectious agent via an authorized medicinal product; or other situations.
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; abnormal pregnancy outcome (for example, spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy); is a suspected transmission of any infectious agent via an authorized medicinal product; or other situations
Number of participants with clinically significant changes in blood laboratory values will be evaluated.
Number of participants with clinically significant changes in blood laboratory values will be evaluated.
Number of participants with clinically significant changes in Urine laboratory values will be evaluated.
Number of participants with clinically significant changes in Urine laboratory values will be evaluated.
Number of participants with clinically significant changes in vital signs (will be evaluated.
Number of participants with clinically significant changes in vital signs will be evaluated.
Number of participants with clinically significant changes in 12-lead ECG parameters will be evaluated.
Number of participants with clinically significant changes in 12-lead ECG parameters will be evaluated.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Part A: Cohort 1: Participants receiving GSK4771261 Dose level 1 | EXPERIMENTAL | Healthy participants will be randomized to receive GSK4771261 Dose level 1. |
| Part A: Cohort 2 : Participants receiving GSK4771261 Dose level 2 | EXPERIMENTAL | Healthy participants will be randomized to receive GSK4771261 Dose level 2. |
| Part A: Cohort 3: Participants receiving GSK4771261 Dose level 3 | EXPERIMENTAL | Healthy participants will be randomized to receive GSK4771261 Dose level 3. |
| Part A: Cohort 4: Participants receiving GSK4771261 Dose level 4 | EXPERIMENTAL | Healthy participants will be randomized to receive GSK4771261 Dose level 4. |
| Part A: Cohort 5: Participants receiving GSK4771261 Dose level 5 | EXPERIMENTAL | Healthy participants will be randomized to receive GSK4771261 Dose level 5. |
| Part A: Cohort 6: Participants receiving GSK4771261 Dose level 6 | EXPERIMENTAL | Healthy participants will be randomized to receive GSK4771261 Dose level 6. |
| Part A: Cohort 7 (optional): Participants receiving GSK4771261 Dose level 7 | EXPERIMENTAL | Healthy participants will be randomized to receive GSK4771261 Dose level 7 as the recommendation of Dose escalation committee (DEC). |
| Part A: Cohort 8 (optional): Participants receiving GSK4771261 Dose level 8 | EXPERIMENTAL | Healthy participants will be randomized to receive GSK4771261 Dose level 8, as per the recommendation from DEC. |
| Part B: Cohort 1: Participants receiving GSK4771261 Dose level 9 | EXPERIMENTAL | Participant with Autosomal dominant polycystic kidney disease (ADPKD) will be randomized to receive GSK4771261 Dose level 9. |
| Part B: Cohort 2: Participants receiving GSK4771261 Dose level 10 | EXPERIMENTAL | Participant with ADPKD will be randomized to receive GSK4771261 Dose level 10. |
| Part B: Cohort 3: Participants receiving GSK4771261 Dose level 11 | EXPERIMENTAL | Participant with ADPKD will be randomized to receive GSK4771261 Dose level11. |
| Part B: Cohort 4 (optional): Participants receiving GSK4771261 Dose level 12 | EXPERIMENTAL | Participant with ADPKD will be randomized to receive GSK4771261 Dose level 12 as the recommendation from DEC. |
| Part B: Cohort 5 (optional): Participants receiving GSK4771261 Dose level 13 | EXPERIMENTAL | Participant with ADPKD will be randomized to receive GSK4771261 Dose level 13, as per the recommendation from DEC. |
| Part A: Participants receiving Placebo matching GSK4771261 | PLACEBO_COMPARATOR | Participants will receive placebo matching GSK4771261 |
| Part B: Participants receiving placebo matching GSK4771261 | PLACEBO_COMPARATOR | Participants will receive placebo matching GSK4771261 |
| Name | Type | Description |
|---|---|---|
| GSK4771261 | DRUG | GSK4771261 will be administered. |
| Placebo | DRUG | Placebo will be administered. |
| Placebo matching GSK4771261 | DRUG | Placebo matching GSK4771261 will be administered. |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusi...