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Recruiting Phase 1

A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants

NCT07789899 · tracked via the Priya Life Science UK tracker
Phase
Phase 1
Started
2026-08-18
Last updated
2026-09-01

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

GSK3862995B →

GSK3862995B: GSK3862995B will be administered.

Study summary

This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Participants who are generally healthy as determined by medical evaluation including medical history, physical examination laboratory tests, and cardiac monitoring * Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants * Body Mass Index (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m\^2) (inclusive) * Male, or female of non-childbearing potential (PONCBP) Exclusion Criteria: * Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints. * A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, hepatitis B or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening * Abnormal blood pressure (as determined by the investigator) * Symptomatic herpes zoster within 3 months prior to screening * 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 immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis) * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * Breast cancer within the past 10 years * Alanine transaminase (ALT) greater than (\>)1.0x upper limit of normal (ULN) * Total bilirubin \>1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5 x ULN as long as direct bilirubin is less than or equal to (\<=) 1.5 x ULN * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * A clinically significant abnormality in the average of triplicate 12-lead ECG readings performed at screening

Primary outcome measure(s)

  • Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B — From pre-dose on Day 1 through Week 36
  • Maximum Observed Serum Concentration (Cmax) of GSK3862995B — From pre-dose on Day 1 through Week 36
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to Week 49
  • Number of Participants With Clinically Significant Changes in Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) Findings — Up to Week 36

Trial sites (1)

FacilityCityRegionStatus
GSK Investigational Site Cambridge United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07789899 on ClinicalTrials.gov ↗ ← All trials in the UK