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GSK4771261 · 2 trials · 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 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...
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GSK4771261 is an investigational small molecule being developed for kidney disease, specifically studied in participants with autosomal dominant polycystic kidney disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
GSK4771261 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and effects on blood and urine markers.
GSK4771261 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for any use. Two Phase 1 trials are listed, one active and one not yet recruiting, both involving healthy participants and those with kidney disease.
GSK4771261 is being studied in two Phase 1 trials. NCT06734234 evaluates single ascending doses in healthy participants and those with autosomal dominant polycystic kidney disease, with 86 enrolled. NCT07600450 is a study in healthy participants aged 25 to 55, with 30 planned participants.
Yes, GSK4771261 is being studied in autosomal dominant polycystic kidney disease. The trial NCT06734234 includes participants with this condition and healthy volunteers, assessing safety, tolerability, and effects on blood and urine markers. The trial is active but not recruiting.