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 (MAPLE)
Polycystic kidney disease, Genetic Kidney Disease · GlaxoSmithKline
This Phase 1a/1b randomized, double-blind, placebo-controlled trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK4771261. Part A assesses single ascending doses in healthy participants to determine the drug's safety profile and systemic impact. Part B investigates the intervention in patients with autosomal dominant polycystic kidney disease (ADPKD) to establish initial clinical data in the target population. The study monitors standard safety parameters and physiological responses to inform future dosing strategies for chronic kidney disease management.