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RECRUITING
NCT06734234
PHASE1

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-12-11

Completion Date

2026-09-04

Last Updated

2025-08-07

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

GSK4771261

GSK4771261 will be administered.

DRUG

Placebo matching GSK4771261

Placebo matching GSK4771261 will be administered.

Locations (14)

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Brest, France

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Cambridge, United Kingdom

GSK Investigational Site

Exeter, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Newcastle upon Tyne, United Kingdom