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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT06734234•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

25 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•For Part A
•Body weight greater than or equal to (\>=) 45 kilograms (kg) and basal metabolic index (BMI) within the range 19.5 to 32 kilograms per square meters (kg/m\^2), inclusive
•Capable of giving signed informed consent,
•Participants who are overtly healthy as determined by medical evaluation by the investigator or a medically qualified designee based on medical history, physical examination, laboratory tests, and cardiac monitoring
•Women must be of non-childbearing potential
•For Part B (planned Cohorts 1-3 and optional cohorts 4-5):
•Body weight \>=45 kg and BMI within the range 19.5 to 32 kg/m\^2, inclusive.
•Capable of giving signed informed consent, Confirmed diagnosis of Autosomal dominant polycystic kidney disease (ADPKD) by either applicable guidelines and/or genetic and imaging screening assessments
•Participants diagnosed with ADPKD may have complications or comorbidities directly related to ADPKD but should be otherwise healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests clinical testing
•Confirmation of known ADPKD causal genetic mutation(s) at the Polycystic kidney disease (PKD)1 and/or PKD2 loci based on genetic testing at screening and/or existing genetic information collected during the participant's routine clinical care for ADPKD from a genetic testing provider that, in the judgement of the investigator, is clinically valid.
+10 more criteria

Exclusion Criteria

•For Part A:
•History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data.
•History of malignancy of any type.
•History of kidney disease or kidney abnormalities or eGFR less than (\<) 90 milliliters per minute per 1.73 square meters (mL/min/1.73m\^2) (based on the chronic kidney disease- Epidemiology Collaboration \[CKD-EPI\] 2021 eGFR equation) at screening.
•Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug and for the duration of study participation.
•QT interval corrected (QTc)\>450 milliseconds (msec)
•Participation in this study would result in loss of blood or blood products in excess of 500 mL within 56 days
•Current enrolment or past participation in an investigational clinical trial in which an investigational medicinal product was administered within the following time periods prior to the first dosing day of the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer
•Exposure to more than 4 investigational medicinal products within 12 months prior to dosing
•Significant allergy to humanized monoclonal antibodies
+63 more criteria

Locations (14)

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Brest, France

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

Key Dates

Start Date

December 11, 2024

Primary Completion Date

September 4, 2026

Completion Date

September 4, 2026

Last Updated

August 7, 2025

Enrollment

ESTIMATED participants

Conditions

Kidney Disease

Interventions

GSK4771261

DRUG

Placebo matching GSK4771261

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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