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)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Rochester, Minnesota
Age range: 25 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- GSK Investigational Site — Rochester, Minnesota
- GSK Investigational Site — Brussels,
- GSK Investigational Site — Ghent,
- GSK Investigational Site — Leuven,
- GSK Investigational Site — London, Ontario
- GSK Investigational Site — Toronto, Ontario
- GSK Investigational Site — Montreal, Quebec
- GSK Investigational Site — Brest,
- GSK Investigational Site — Paris,
- GSK Investigational Site — Cologne, North Rhine-Westphalia
- GSK Investigational Site — Lübeck, Schleswig-Holstein
- GSK Investigational Site — Groningen,
- GSK Investigational Site — Leiden,
- GSK Investigational Site — Rotterdam,
- GSK Investigational Site — Barcelona,
- GSK Investigational Site — Barcelona,
- GSK Investigational Site — Barcelona,
- GSK Investigational Site — Madrid,
- GSK Investigational Site — Madrid,
- GSK Investigational Site — Cambridge,
- GSK Investigational Site — Exeter,
- GSK Investigational Site — London,
- GSK Investigational Site — Newcastle upon Tyne,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.