Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06154837

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

Led by GlaxoSmithKline · Updated on 2025-07-18

130

Participants Needed

32

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy participants aged 18 to 65 years inclusive
  • Healthy participants must be overtly healthy based on medical evaluation including history, physical exam, lab tests, and cardiac monitoring
  • Body weight between 50 and 110 kg inclusive
  • Body mass index between 19.5 and 32 kg/m2 inclusive
  • Male or female of non-childbearing potential
  • Participants with COPD aged 40 to 75 years inclusive
  • COPD participants must have confirmed diagnosis for more than 12 months
  • Post-salbutamol FEV1/FVC ratio less than 0.70 and FEV1 at least 40% of predicted normal
  • COPD participants require optimized standard of care including daily inhaled medication
  • Peripheral blood eosinophil count of at least 150 cells/microliter
  • COPD participants may be former smokers with at least 10 pack-years or current smokers or non-smokers
  • Male or female of non-childbearing potential
Not Eligible

You will not qualify if you...

  • Medical conditions not well controlled that may affect safety or study results
  • History of recurrent infections or treatment of chronic infection within 3 months before first dose
  • Significant allergies to humanized monoclonal antibodies
  • Severe drug allergies, intolerance to topical corticosteroids, or severe hypersensitivity reactions
  • Lymphoma, leukemia, or malignancy within past 5 years except certain skin cancers resected with no metastasis for 3 years
  • Breast cancer within past 10 years
  • Alanine transaminase (ALT) above 1x upper limit of normal
  • Total bilirubin above 1.5x upper limit of normal unless fractionated with direct bilirubin less than 35%
  • Current or chronic liver disease or biliary abnormalities except Gilbert's syndrome or asymptomatic gallstones
  • Clinically significant abnormalities in 12-lead ECG at screening
  • Clinically significant abnormalities in Holter monitor at screening (IV cohorts only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 32 locations

1

GSK Investigational Site

Yuma, Arizona, United States, 85365

Actively Recruiting

2

GSK Investigational Site

Hialeah, Florida, United States, 33016

Actively Recruiting

3

GSK Investigational Site

Plantation, Florida, United States, 33324

Actively Recruiting

4

GSK Investigational Site

Columbus, Georgia, United States, 31904

Actively Recruiting

5

GSK Investigational Site

Shelby, North Carolina, United States, 28150

Actively Recruiting

6

GSK Investigational Site

Wilmington, North Carolina, United States, 28412

Actively Recruiting

7

GSK Investigational Site

Medford, Oregon, United States, 97504

Actively Recruiting

8

GSK Investigational Site

Rock Hill, South Carolina, United States, 29732

Actively Recruiting

9

GSK Investigational Site

Austin, Texas, United States, 78744

Actively Recruiting

10

GSK Investigational Site

Ahrensburg, Germany, 22926

Actively Recruiting

11

GSK Investigational Site

Berlin, Germany, 10117

Actively Recruiting

12

GSK Investigational Site

Berlin, Germany, 10119

Actively Recruiting

13

GSK Investigational Site

Berlin, Germany, 14050

Actively Recruiting

14

GSK Investigational Site

Dresden, Germany, 01069

Actively Recruiting

15

GSK Investigational Site

Frankfurt, Germany, 60596

Actively Recruiting

16

GSK Investigational Site

Hamburg, Germany, 20253

Actively Recruiting

17

GSK Investigational Site

Hamburg, Germany, Hamburg

Actively Recruiting

18

GSK Investigational Site

Hanover, Germany, 30159

Actively Recruiting

19

GSK Investigational Site

Immenhausen, Germany, 34376

Actively Recruiting

20

GSK Investigational Site

Leipzig, Germany, 04207

Actively Recruiting

21

GSK Investigational Site

Lübeck, Germany, 23552

Actively Recruiting

22

GSK Investigational Site

Mainz, Germany, 55128

Actively Recruiting

23

GSK Investigational Site

München, Germany, 81241

Actively Recruiting

24

GSK Investigational Site

Schwerin, Germany, 19055

Actively Recruiting

25

GSK Investigational Site

Barnsley, United Kingdom, S75 3DL

Actively Recruiting

26

GSK Investigational Site

Blackpool, United Kingdom, FY2 0JH

Actively Recruiting

27

GSK Investigational Site

Cambridge, United Kingdom, CB2 0GG

Actively Recruiting

28

GSK Investigational Site

Cannock, United Kingdom, WS11 0BN

Actively Recruiting

29

GSK Investigational Site

London, United Kingdom, HA1 3UJ

Actively Recruiting

30

GSK Investigational Site

London, United Kingdom

Actively Recruiting

31

GSK Investigational Site

Manchester, United Kingdom, M23 9QZ

Actively Recruiting

32

GSK Investigational Site

West Yorkshire, United Kingdom, LS10 1DU

Actively Recruiting

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Research Team

U

US GSK Clinical Trials Call Center

CONTACT

E

EU GSK Clinical Trials Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

9

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