A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease

Last updated: April 24, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

GSK3862995B

Placebo

Clinical Study ID

NCT06154837
221531
2023-506880-32-00
2023-506880-32
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Healthy participants (Part A)

  • Participant must be 18 to 65 years of age inclusive.

  • Participants who are overtly healthy as determined by medical evaluation includingmedical history, physical examination, laboratory tests, and cardiac monitoring

  • Body weight within the range 50-110 kilogram (kg) (inclusive)

  • Body mass index (BMI) within the range 19.5-32 kilogram per square meter (kg/m^2)

  • Male and/or female of non-childbearing potential

Participants with Chronic Obstructive Pulmonary Disorder (COPD) (Part B)

  • Participant must be 40 to 75 years of age inclusive.

  • Body weight within the range 50-110 kg (inclusive)

  • BMI within the range 19.5-32 kg/m^2

  • Participant has a confirmed diagnosis of COPD for greater than (>)12 months

  • Participants must present with a measured post-salbutamol Forced expiratory volumein 1 second/Forced vital capacity (FEV1/FVC) ratio of less than (<) 0.70 atscreening to confirm the diagnosis of COPD and a measured post-salbutamol FEV1greater than or equal to (>=) 40% of predicted normal values.

  • Participants must have a well-documented requirement for optimized standard of carebackground therapy that includes daily inhaled medication.

  • A peripheral blood eosinophil count of >=150 cells/microliter (mcL) at screening

  • Former cigarette smokers with a history of cigarette smoking of >=10 pack-years atscreening current smokers (includes the use of any type of nicotine containingproduct), or non-smokers are permitted

  • Male and/or female of non-childbearing potential.

Exclusion

Exclusion Criteria:

  • Participant has a past or current medical condition(s) or disease(s) that is/are notwell controlled and, which in the judgement of the Investigator, may affectparticipant safety or affect study endpoints.

  • A history of recurrent infections, or treatment of a chronic infection within 3months prior to the first dose of study drug, including both serious local infection (for example, cellulitis, abscess) or systemic infection (for example, pneumonia,tuberculosis, hepatitis B, shingles).

  • Significant allergies to humanized monoclonal antibodies.

  • Clinically significant multiple or severe drug allergies, intolerance to topicalcorticosteroids, or severe post-treatment hypersensitivity reactions (including, butnot 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 cellor squamous epithelial carcinomas of the skin that have been resected with noevidence of metastatic disease for 3 years.

  • Breast cancer within the past 10 years

  • Alanine transaminase (ALT) >1x upper limit of normal (ULN)

  • Total bilirubin >1.5xULN (isolated total bilirubin >1.5xULN is acceptable if totalbilirubin is fractionated and direct bilirubin less than (<) 35%).

  • Current or chronic history of liver disease or known hepatic or biliaryabnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

  • A clinically significant abnormality in 12-lead ECG readings performed at screening

  • A clinically significant abnormality in the Holter monitor performed at screening (IV cohorts only).

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: GSK3862995B
Phase: 1
Study Start date:
November 27, 2023
Estimated Completion Date:
June 26, 2026

Connect with a study center

  • GSK Investigational Site

    Berlin, 14050
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Dresden, 01069
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Frankfurt, 60596
    Germany

    Site Not Available

  • GSK Investigational Site

    Grosshansdorf, 22927
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 20253
    Germany

    Site Not Available

  • GSK Investigational Site

    Hannover, 30159
    Germany

    Site Not Available

  • GSK Investigational Site

    Immenhausen, 34376
    Germany

    Site Not Available

  • GSK Investigational Site

    Leipzig, 04207
    Germany

    Site Not Available

  • GSK Investigational Site

    Luebeck, 23552
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Mainz, 55128
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenchen, 81241
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Schwerin, 19055
    Germany

    Site Not Available

  • GSK Investigational Site

    Barnsley, S75 3DL
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Blackpool, FY2 0JH
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Cambridge, CB2 0GG
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Cannock, WS11 0BN
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    London,
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Manchester, M23 9QZ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    West Yorkshire, LS10 1DU
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

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