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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 by GSK plc for kidney disease. It is in Phase 1 clinical development and has not been approved for any indication. The program includes two active early-stage trials evaluating the compound in healthy participants and in participants with autosomal dominant polycystic kidney disease.
GSK4771261 is being studied for kidney disease, including autosomal dominant polycystic kidney disease. It remains investigational and is not approved for any use. Clinical work so far is limited to Phase 1 studies assessing safety, tolerability, and effects on blood and urine markers in healthy participants and in participants with autosomal dominant polycystic kidney disease.
GSK4771261 is developed by GSK plc, which trades under the ticker GSK. The company is running the Phase 1 program for the compound in kidney disease, with studies conducted across sites in Europe and North America.
GSK4771261 is in Phase 1 clinical development. Two Phase 1 trials are active, one recruiting and one active but not recruiting, with a combined planned enrollment of 116 participants. The drug is investigational and has not been approved by the FDA or any other regulator.
GSK4771261 is being studied in two Phase 1 trials. NCT07600450 is a recruiting study in healthy participants aged 25 to 55 in the Netherlands, enrolling 30 people. NCT06734234 is active but not recruiting, enrolling 86 healthy participants and participants with autosomal dominant polycystic kidney disease across the United States, Belgium, Canada, France, Germany, Netherlands, Spain, and the United Kingdom.
Yes. The GSK4771261 Phase 1 program is randomized, double blind, and placebo controlled. The two studies together plan to enroll 116 participants, and both are in kidney disease, with one focused on healthy volunteers and the other including participants with autosomal dominant polycystic kidney disease.