A Study of GSK4771261 in Healthy Participants Aged 25 to 55 Years of Age Inclusive

NCT07600450 | Not Yet Recruiting Phase 1

• 2 other identifiers: 2213772025-525073-37
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a first time in Asia (FTIA) study of GSK4771261 in healthy participants of Chinese, Japanese, and White/European ancestry. The study will test whether GSK4771261 is safe, well-tolerated, how it is processed in the body, and whether it triggers an immune response.

Conditions

Kidney Disease

Keywords

GSK4771261; Healthy Volunteers; Pharmacokinetics; Pharmacodynamics; Immunogenicity; Chinese Ancestry; Japanese Ancestry; White/European Ancestry

Outcome Measures

Primary Outcomes (7)

• Number of Participants with Adverse Events (AEs), Injection Site Reactions, and Serious AEs (SAEs)

  Up to Week 13 (End of Study)

• Number of Participants with Clinically Significant Changes from Baseline in Vital Signs

  Up to Week 13 (End of Study)

• Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Values

  Up to Week 13 (End of Study)

• Number of Participants with Clinically Significant Changes from Baseline in 12-Lead Electrocardiogram (ECG)

  Up to Week 13 (End of Study)

• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-t])

  Up to Week 13

• Area under the serum concentration-time curve extrapolated to infinite time (AUC[0-inf])

  Up to Week 13

• Maximum observed serum concentration (Cmax)

  Up to Week 13

Secondary Outcomes (2)

• Number of Participants with pre-existing Anti-Drug Antibodies (ADAs)

  Up to Week 13 (End of Study)

• Number of Participants with treatment-emergent ADAs

  Up to Week 13 (End of Study)

Study Arms (2)

GSK4771261

EXPERIMENTAL

Healthy participants of Chinese, Japanese, or White/European ancestry will receive GSK4771261.

Drug: GSK4771261

Placebo

EXPERIMENTAL

Healthy participants of Chinese, Japanese, or White/European ancestry will receive Placebo.

Drug: Placebo

Interventions

GSK4771261 DRUG

GSK4771261 will be administered.

GSK4771261

Placebo DRUG

Placebo will be administered.

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants at screening
• Body Mass Index (BMI) within the range of 18.0 - 28.0 kilogram per square meters (kg/m\^2) (inclusive) at screening
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and is a Participant of non-childbearing potential (PONCBP)
• Capable of giving signed informed consent
• Participants of Chinese ancestry or Japanese ancestry or White/European ancestry are eligible based on meeting all the following criteria:
• Participants of Chinese ancestry: Born in mainland China, Hong Kong, or Taiwan; descendant of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents; and have lived outside mainland China, Hong Kong, or Taiwan for less than 10 years at the time of screening
• Participants of Japanese ancestry: born in Japan; descendant of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents; and have lived outside Japan for less than 10 years at the time of screening
• Participants of White/European ancestry: Self-identified as being of White/European ancestry (i.e., from the original peoples of Europe) irrespective of place of birth and current place of residence; and descendant of 4 grandparents and 2 parents of White/European ancestry (i.e., from the original peoples of Europe) irrespective of place of birth or current place of residence.
• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
• History of kidney disease or kidney abnormalities or Estimated glomerular filtration rate (eGFR) less than (\<) 90 millilitres per minute per 1.73 square meter (mL/min/1.73m\^2) (based on the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] 2021 eGFR equation) at screening and on Day -1
• Significant allergies to humanized monoclonal antibodies
• Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
• Current or previous diagnosis of diabetes mellitus (type 1 or type 2)
• Glycosylated hemoglobin (HbA1c) greater than or equal (\>=)39 millimoles per mole (mmol/mol) at screening
• Bone fracture within 6 months prior to screening, or presence of a known unresolved or incompletely resolved fracture

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.