A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of GSK4771261 in Healthy Volunteers

This study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics following the administration of a single subcutaneous dose of GSK4771261. The investigation focuses on characterizing the initial physiological response and metabolic profile of the compound in healthy participants. The primary aim is to establish the safety profile and the drug's behavior in the human body, which is a critical requirement for subsequent clinical development in the treatment of Autosomal Dominant Polycystic Kidney Disease.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers of both genders within the age range corresponding to code 3. The research focuses on individuals associated with Autosomal Dominant Polycystic Kidney Disease.

This Phase 3 clinical trial is designed to investigate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of a single subcutaneous dose of GSK4771261. The study involves healthy participants between the ages of 25 and 55 years inclusive. The research methodology focuses on evaluating the effects of the investigational product in a controlled setting. The study procedure includes a screening visit to assess eligibility, followed by subsequent visits to monitor biological responses and physiological parameters. The sequence of visits concludes with an end-of-study visit. The total duration of participant involvement is determined by the scheduled follow-up intervals. Study termination may occur if specific clinical criteria or safety conditions are met.

The clinical trial is designed to evaluate the efficacy of an investigational intervention in patients diagnosed with Autosomal Dominant Polycystic Kidney Disease. Assessment of efficacy will be conducted within the framework of a Phase 3 study.