A study to evaluate the safety, tolerability, PK and PD of GSK4771261 in FTIHV and FTIP
Research type
Research Study
Full 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.
IRAS ID
1010572
Contact name
Suzan Yuen
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2024-516095-15
Clinicaltrials.gov Identifier
Research summary
This is a study in which GSK4771261 will be given for the first time humans. The study is being done on healthy people (Part A) and people with a kidney disease called ADPKD (Part B). Its purpose is to check how safe and tolerable this drug is and understand how it moves in the body, how it is removed (pharmacokinetics), how it affects the body (pharmacodynamics), and how the body's immune system responds to it (immunogenicity).
The study drug will be injected only once either under the skin (subcutaneous) or slowly in a vein (intravenous). In Part A, healthy participants will stay in the clinical unit for 8 or 5 days if they take the subcutaneous or intravenous injection respectively. In Part B, ADPKD patients will take the injection during an outpatient clinic visit. There will be an outpatient follow up period of approximately 26 weeks through outpatient clinic visits and telephone calls in both Part A and B.
Different doses of GSK4771261 will be given in up to 8 groups (cohorts) of 8 healthy individuals, and 5 cohorts of 12 ADPKD patients each. Participants in each cohort will take the same dose level. In healthy cohorts, 6 participants will take GSK4771261 (active) and 2 a dummy drug (placebo). In patient cohorts, 9 participants will take active and 3 placebo. Treatment will be randomly allocated and neither the clinical staff nor the participants will know whether on active or placebo. Within each healthy cohort, 2 participants (sentinels) will take the study intervention first; 1 of whom will take active and 1 placebo. Their safety will be checked by the investigators for a minimum of 8 days and 48 hours for subcutaneous and intravenous administration respectively, to decide if it is safe to give the drug to the rest of the group. Doses used in ADPKD patients at any time will be the same or lower than the ones used in healthy participants, and will be decided only when safety information from the same dose in healthy participants has been reviewed first.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0311
Date of REC Opinion
25 Nov 2024
REC opinion
Further Information Favourable Opinion