Phase
Condition
N/ATreatment
GSK3862995B
Placebo
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
GSK Investigational Site
Berlin, 14050
GermanyActive - Recruiting
GSK Investigational Site
Dresden, 01069
GermanyActive - Recruiting
GSK Investigational Site
Frankfurt, 60596
GermanySite Not Available
GSK Investigational Site
Grosshansdorf, 22927
GermanySite Not Available
GSK Investigational Site
Hamburg, 20253
GermanySite Not Available
GSK Investigational Site
Hannover, 30159
GermanySite Not Available
GSK Investigational Site
Immenhausen, 34376
GermanySite Not Available
GSK Investigational Site
Leipzig, 04207
GermanySite Not Available
GSK Investigational Site
Luebeck, 23552
GermanyActive - Recruiting
GSK Investigational Site
Mainz, 55128
GermanySite Not Available
GSK Investigational Site
Muenchen, 81241
GermanyActive - Recruiting
GSK Investigational Site
Schwerin, 19055
GermanySite Not Available
GSK Investigational Site
Barnsley, S75 3DL
United KingdomActive - Recruiting
GSK Investigational Site
Blackpool, FY2 0JH
United KingdomActive - Recruiting
GSK Investigational Site
Cambridge, CB2 0GG
United KingdomActive - Recruiting
GSK Investigational Site
Cannock, WS11 0BN
United KingdomActive - Recruiting
GSK Investigational Site
London,
United KingdomActive - Recruiting
GSK Investigational Site
Manchester, M23 9QZ
United KingdomSite Not Available
GSK Investigational Site
West Yorkshire, LS10 1DU
United KingdomActive - Recruiting
GSK Investigational Site
Rock Hill, South Carolina 29732
United StatesActive - Recruiting
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