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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
Led by GlaxoSmithKline · Updated on 2025-08-07
84
Participants Needed
14
Research Sites
90 weeks
Total Duration
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AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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...
- Body weight at least 45 kilograms and BMI between 19.5 and 32 kg/m²
- Able to give signed informed consent
- For healthy participants: overtly healthy by medical evaluation including history, exam, labs, and cardiac monitoring
- For healthy participants: women must be of non-childbearing potential
- For ADPKD participants: confirmed diagnosis of autosomal dominant polycystic kidney disease by guidelines or genetic and imaging tests
- ADPKD participants may have related complications but otherwise healthy by medical evaluation
- Confirmed genetic mutation in PKD1 and/or PKD2 genes for ADPKD participants
- 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 expected stable kidney function
- Intolerant, unwilling, or ineligible for tolvaptan treatment for ADPKD
- Female participants not pregnant or breastfeeding and agree to use birth control if applicable
- Women of childbearing potential must have negative pregnancy tests before MRI and before first dose
- For optional ADPKD cohorts 4-5: eGFR at least 30 mL/min/1.73m², stable clinical condition, and no expected kidney function decline or need for renal replacement therapy in 12 months
- No clinical, biochemical, or family signs of significant kidney function decline expected in 12 months
You will not qualify if you...
- History or presence of major cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or neurological disorders altering drug absorption or posing risk
- History of any cancer
- Kidney disease or abnormalities or eGFR below 90 mL/min/1.73m² in healthy participants
- Use of prescription or non-prescription drugs, vitamins, or supplements within 7 days or 5 half-lives before dosing
- QT interval corrected (QTc) over 450 milliseconds
- Excessive blood loss risk over 500 mL within 56 days
- Participation in other investigational drug trials recently or exposure to more than 4 investigational drugs in past 12 months
- Significant allergies to monoclonal antibodies or severe drug allergies
- Pregnant or breastfeeding females
- Diagnosis of diabetes or HbA1c 6.5% or higher
- Recent bone fractures or unresolved fractures
- Positive drug, alcohol, HIV, hepatitis B or C, or SARS-CoV-2 tests
- Abnormal blood clotting or blood disorders
- Regular recreational drug use or inability to avoid smoking or vaping during study
- Poor venous access if IV administration needed
- High alcohol intake exceeding 14 UK units per week
- Sensitivity or allergy to study drugs or components
- Use of unapproved medical products like herbal or homeopathic remedies
- Elevated liver enzymes or history of liver disease except Gilbert's syndrome or asymptomatic gallstones
- Contraindications to MRI or unwillingness to undergo MRI
- Kidney cyst interventions or infections recently or planned
- Abnormal urine tests or significant proteinuria
- Recent tolvaptan treatment within 6 months
- Incompletely healed wounds or planned surgery during study
- Clinically significant abnormal blood pressure uncontrolled by stable therapy
- Recent or current malignancies except certain skin cancers
- Breast cancer within past 10 years
- Other conditions that interfere with drug metabolism or study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
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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