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

A Randomised, Double Blind, Placebo-controlled, Single Ascending Dose, Phase 1a/1b Multi-centre Study in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK4771261

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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

• Kidney Disease

Interventions

Type	Name	Description
DRUG	GSK4771261	GSK4771261 will be administered.
DRUG	Placebo matching GSK4771261	Placebo matching GSK4771261 will be administered.

Timeline

• Start date: 2024-12-11
• Primary completion: 2026-09-04
• Completion: 2026-09-04
• First posted: 2024-12-16
• Last updated: 2025-08-07

Locations

14 sites across 6 countries: Belgium, Canada, France, Germany, Spain, United Kingdom