Last updated: 09/29/2025 06:30:07

A study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of GSK3862995B administered as a single dose to healthy participants of Chinese, Japanese, and European ancestry

GSK study ID
223982
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK3862995B Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and European Ancestry
Trial description: This study aims to assess the ethnic sensitivity of GSK3862995B in terms of safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) in healthy participants of Chinese, Japanese, and European ancestry to enable the inclusion of Chinese and Japanese participants in future global studies.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of Participants with Adverse Events (AE)

Timeframe: Up to Week 44 (End of follow up visit)

Number of Participants with Serious Adverse Events (SAE)

Timeframe: Up to Week 44 (End of follow up visit)

Number of Participants with Clinically Significant Changes in Clinical Laboratory Values

Timeframe: Up to Week 36

Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: Up to Week 36

Number of Participants with Clinically Significant Changes in 12-lead (Electrocardiogram (ECG)

Timeframe: Up to Week 36

Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) of GSK3862995B

Timeframe: Up to Week 36

Maximum Observed Concentration (Cmax) of GSK3862995B

Timeframe: Up to Week 36

Secondary outcomes:
Not applicable
Interventions:
  • Drug: GSK3862995B
  • Drug: Placebo
  • Enrollment:
    30
    Primary completion date:
    2025-20-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    May 2025 to April 2026
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 Years
    Accepts healthy volunteers
    Yes
    • Participant must be 18 to 50 years of age inclusive
    • Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, laboratory tests, and cardiac monitoring
    • 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
    • A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cypress, CA, United States, 90630
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Las Vegas, NV, United States, 89113
    Status
    Recruitment Complete

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruitment complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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