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NCT07789899RecruitingPhase 1

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

A Phase 1, Open-Label, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations After a Single Dose in Healthy Participants

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
24 (estimated)
First submitted
24 Aug 2026
Start date
18 Aug 2026
Primary completion date
7 Sept 2027
Lead sponsor
GlaxoSmithKline
Diseases
COPD
NCT number
NCT07789899

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 24
  • From 18 Aug 2026 to the primary completion date, 7 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Symptomatic herpes zoster within 3 months prior to screening

Other illness

  • 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.
  • 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
  • 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

Lab values

  • 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

Other

  • Abnormal blood pressure (as determined by the investigator)

Who the study is looking for

  • 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)

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
CambridgeUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.