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A Randomised, Double Blind, Placebo-controlled, Single Ascending Dose Study in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease to Evaluate Safety, Tolerability, and Effects of GSK4771261
Led by GlaxoSmithKline · Updated on 2025-08-07
84
Participants Needed
14
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new drug called GSK4771261 in a study involving both healthy volunteers and people with a kidney disease named autosomal dominant polycystic kidney disease (ADPKD). The study is designed to understand the drug's safety, how it affects the body, and how it influences the immune system. The trial includes two parts: Part A with healthy participants and Part B with ADPKD patients. Participants in Part A will be randomly assigned to receive one of several increasing doses of GSK4771261 or a matching placebo, while Part B participants with ADPKD will receive higher dose levels of the drug or placebo, based on recommendations from a dose escalation committee. Both groups will undergo a single ascending dose phase to assess the drug's effects at different levels. During the study, participants will be monitored for adverse events, changes in blood and urine tests, vital signs, and heart activity using ECGs, from the first day up to 182 days. Researchers will also measure the drug's concentration in the blood and the development of anti-drug antibodies. Safety and tolerability will be closely tracked throughout the study period, which includes follow-up assessments extending to about six months after dosing.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 25 to 65 years
- Body weight of at least 45 kilograms and BMI between 19.5 and 32 kg/m²
- Able to give signed informed consent
- For healthy participants: must be medically healthy based on evaluation
- For participants with ADPKD: confirmed diagnosis by guidelines or genetic and imaging tests
- ADPKD participants may have related complications but must be otherwise medically stable
- Genetic confirmation of ADPKD mutations in PKD1 or PKD2 genes
- Mayo imaging classification groups 1C, 1D, or 1E for ADPKD participants
- Estimated glomerular filtration rate (eGFR) of at least 45 mL/min/1.73m² and stable kidney function expected
- ADPKD participants intolerant, unwilling, or ineligible for tolvaptan treatment
- Women not pregnant or breastfeeding and agreeing to use birth control
- Negative pregnancy test before MRI and before first dose for women of childbearing potential
- Additional criteria for optional ADPKD cohorts include eGFR ≥30 mL/min/1.73m², clinical stability over 24 months, and no expected need for renal replacement therapy in 12 months
You will not qualify if you...
- History or presence of serious medical conditions affecting organs or drug metabolism
- History of any cancer
- Kidney disease or abnormalities in healthy participants, with eGFR less than 90 mL/min/1.73m²
- Use of prescription or non-prescription drugs, vitamins, or supplements within 7 days before dosing
- QTc interval over 450 milliseconds
- Loss of more than 500 mL blood within 56 days due to study
- Recent participation in other investigational drug trials
- Exposure to more than four investigational drugs in the past year
- Significant allergies to monoclonal antibodies or severe drug allergies
- Pregnant or breastfeeding females
- Diagnosis of diabetes or high HbA1c at screening
- Recent bone fractures
- Positive drug or alcohol screens
- Positive tests for HIV, hepatitis B or C, or COVID-19
- Clinically significant hematological disorders or blood clotting problems
- Regular use of recreational drugs or inability to refrain from tobacco during study
- Poor venous access for IV administration
- High weekly alcohol intake above 14 UK units
- Sensitivity or allergy to study drugs or components
- Use of unapproved medical products
- Elevated liver enzymes or bilirubin beyond set limits
- Liver disease or biliary abnormalities except certain mild conditions
- Contraindications to MRI or unwillingness to have MRI
- Certain kidney cyst interventions or infections prior to screening
- Abnormal urine tests indicating kidney issues
- Recent tolvaptan treatment within 6 months
- Unhealed wounds or planned surgery during study
- High blood pressure beyond defined limits or unstable antihypertensive therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dosing with monitoring up to Day 182
Participants receive a single ascending dose of the study drug or placebo to evaluate safety, tolerability, and effects on blood and urine markers.
Multiple visits from Baseline (Day 1) up to Day 182 for assessments
Duration - Up to Day 182 after dosing
Participants are monitored for safety and tolerability after dosing, including laboratory tests and vital sign assessments.
Multiple follow-up visits up to Day 182
Trial Site Locations
Total: 14 locations
1
GSK Investigational Site
Brussels, Belgium, 1200
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2
GSK Investigational Site
Leuven, Belgium, 3000
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3
GSK Investigational Site
London, Ontario, Canada, N6A 5A5
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4
GSK Investigational Site
Montreal, Quebec, Canada, H4J 1C5
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5
GSK Investigational Site
Brest, France, 29200
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6
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany, 50937
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7
GSK Investigational Site
Barcelona, Spain, 08003
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8
GSK Investigational Site
Barcelona, Spain, 08035
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9
GSK Investigational Site
Madrid, Spain, 28040
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10
GSK Investigational Site
Madrid, Spain, 28041
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11
GSK Investigational Site
Cambridge, United Kingdom, CB2 0GG
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12
GSK Investigational Site
Exeter, United Kingdom, EX2 5DW
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13
GSK Investigational Site
London, United Kingdom, NW3 2QG
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14
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE1 4LP
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Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
15
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