Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 32 locations
1
GSK Investigational Site
Yuma, Arizona, United States, 85365
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2
GSK Investigational Site
Hialeah, Florida, United States, 33016
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3
GSK Investigational Site
Plantation, Florida, United States, 33324
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4
GSK Investigational Site
Columbus, Georgia, United States, 31904
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5
GSK Investigational Site
Shelby, North Carolina, United States, 28150
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6
GSK Investigational Site
Wilmington, North Carolina, United States, 28412
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7
GSK Investigational Site
Medford, Oregon, United States, 97504
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8
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
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9
GSK Investigational Site
Austin, Texas, United States, 78744
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10
GSK Investigational Site
Ahrensburg, Germany, 22926
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11
GSK Investigational Site
Berlin, Germany, 10117
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12
GSK Investigational Site
Berlin, Germany, 10119
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13
GSK Investigational Site
Berlin, Germany, 14050
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14
GSK Investigational Site
Dresden, Germany, 01069
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15
GSK Investigational Site
Frankfurt, Germany, 60596
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16
GSK Investigational Site
Hamburg, Germany, 20253
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17
GSK Investigational Site
Hamburg, Germany, Hamburg
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18
GSK Investigational Site
Hanover, Germany, 30159
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19
GSK Investigational Site
Immenhausen, Germany, 34376
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20
GSK Investigational Site
Leipzig, Germany, 04207
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21
GSK Investigational Site
Lübeck, Germany, 23552
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22
GSK Investigational Site
Mainz, Germany, 55128
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23
GSK Investigational Site
München, Germany, 81241
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24
GSK Investigational Site
Schwerin, Germany, 19055
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25
GSK Investigational Site
Barnsley, United Kingdom, S75 3DL
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26
GSK Investigational Site
Blackpool, United Kingdom, FY2 0JH
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27
GSK Investigational Site
Cambridge, United Kingdom, CB2 0GG
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28
GSK Investigational Site
Cannock, United Kingdom, WS11 0BN
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29
GSK Investigational Site
London, United Kingdom, HA1 3UJ
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30
GSK Investigational Site
London, United Kingdom
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31
GSK Investigational Site
Manchester, United Kingdom, M23 9QZ
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32
GSK Investigational Site
West Yorkshire, United Kingdom, LS10 1DU
Actively Recruiting
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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