RecruitingPhase 1NCT06734234

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


Sponsor

GlaxoSmithKline

Enrollment

84 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GSK4771261 and a drug called Placebo matching GSK4771261 for people with kidney disease. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 25 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGSK4771261

GSK4771261 will be administered.

DRUGPlacebo 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

View Full Details on ClinicalTrials.gov

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NCT06734234


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