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
NCT06734234 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2025-08-07
Summary
This is a study where a new drug, called GSK4771261 is being tested. Neither the study doctors, study staff or participants will be aware of what treatment is being given. Part A is testing the new study treatment on healthy people. This is to see if it's safe, what it does to the body, and how the body's defense system responds to it. Part B is similar, but the study treatment will be given to people who have a kidney disease called autosomal dominant polycystic kidney disease (ADPKD).
Conditions
Interventions
- DRUG
-
GSK4771261
GSK4771261 will be administered.
- DRUG
-
Placebo matching GSK4771261
Placebo matching GSK4771261 will be administered.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 25 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-11
- Primary Completion
- 2026-09-04
- Completion
- 2026-09-04
Countries
- Belgium
- Canada
- France
- Germany
- Spain
- United Kingdom
Study Locations
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