A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
NCT ID: NCT06154837
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
130 participants
INTERVENTIONAL
2023-11-27
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part A Dose Level 1: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
GSK3862995B
GSK3862995B will be administered.
Part A Dose Level 2: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
GSK3862995B
GSK3862995B will be administered.
Part A Dose Level 3: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
GSK3862995B
GSK3862995B will be administered.
Part A Dose Level 4: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
GSK3862995B
GSK3862995B will be administered.
Part A Dose Level 5: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
GSK3862995B
GSK3862995B will be administered.
Part A Dose Level 6: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
GSK3862995B
GSK3862995B will be administered.
Part A: Placebo
Healthy participants will receive single dose of placebo.
Placebo
Placebo will be administered.
Part B: Repeat dose of GSK3862995B
Participants with COPD will receive repeat doses of GSK3862995B.
GSK3862995B
GSK3862995B will be administered.
Part B: Placebo
Participants with COPD will receive repeat doses of placebo.
Placebo
Placebo will be administered.
Interventions
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GSK3862995B
GSK3862995B will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* Participant must be 18 to 65 years of age inclusive.
* Participants who are overtly healthy as determined by medical evaluation including medical 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 volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of less than (\<) 0.70 at screening to confirm the diagnosis of COPD and a measured post-salbutamol FEV1 greater than or equal to (\>=) 40% of predicted normal values.
* Participants must have a well-documented requirement for optimized standard of care background 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 at screening current smokers (includes the use of any type of nicotine containing product), or non-smokers are permitted
* Male and/or female of non-childbearing potential.
Exclusion Criteria
* 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 (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 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
* Alanine transaminase (ALT) \>1x upper limit of normal (ULN)
* Total bilirubin \>1.5xULN (isolated total bilirubin \>1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin less than (\<) 35%).
* 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 12-lead ECG readings performed at screening
* A clinically significant abnormality in the Holter monitor performed at screening (IV cohorts only).
18 Years
75 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Yuma, Arizona, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Plantation, Florida, United States
GSK Investigational Site
Columbus, Georgia, United States
GSK Investigational Site
Shelby, North Carolina, United States
GSK Investigational Site
Wilmington, North Carolina, United States
GSK Investigational Site
Medford, Oregon, United States
GSK Investigational Site
Rock Hill, South Carolina, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Ahrensburg, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Dresden, , Germany
GSK Investigational Site
Frankfurt, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Hanover, , Germany
GSK Investigational Site
Immenhausen, , Germany
GSK Investigational Site
Leipzig, , Germany
GSK Investigational Site
Lübeck, , Germany
GSK Investigational Site
Mainz, , Germany
GSK Investigational Site
München, , Germany
GSK Investigational Site
Schwerin, , Germany
GSK Investigational Site
Barnsley, , United Kingdom
GSK Investigational Site
Blackpool, , United Kingdom
GSK Investigational Site
Cambridge, , United Kingdom
GSK Investigational Site
Cannock, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
GSK Investigational Site
West Yorkshire, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-506880-32
Identifier Type: OTHER
Identifier Source: secondary_id
221531
Identifier Type: -
Identifier Source: org_study_id
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