Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
GSK3862995B, Pharmacokinetics, Healthy Volunteers, Phase 1, Safety and Tolerability
Brief summary
This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability.
Interventions
DRUGGSK3862995B
GSK3862995B will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are generally healthy as determined by medical evaluation including medical history, physical examination laboratory tests, and cardiac monitoring * Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants * Body Mass Index (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m\^2) (inclusive) * Male, or female of non-childbearing potential (PONCBP)
Exclusion criteria
* Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints. * 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 (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, hepatitis B or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening * Abnormal blood pressure (as determined by the investigator) * Symptomatic herpes zoster within 3 months prior to screening * 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) greater than (\>)1.0x upper limit of normal (ULN) * Total bilirubin \>1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5 x ULN as long as direct bilirubin is less than or equal to (\<=) 1.5 x ULN * 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 the average of triplicate 12-lead ECG readings performed at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B | From pre-dose on Day 1 through Week 36 |
| Maximum Observed Serum Concentration (Cmax) of GSK3862995B | From pre-dose on Day 1 through Week 36 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 49 |
| Number of Participants With Clinically Significant Changes in Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) Findings | Up to Week 36 |
Countries
United Kingdom
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed