A Phase 1, Open-Label, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations After a Single Dose in Healthy Participants
A Phase 1, Open-Label, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations After a Single Dose in Healthy Participants
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.
Inclusion Criteria:
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)
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