This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants Experiencing Adverse Events (AEs) in Parts A-E
Timeframe: From the first dose of study drug to 30 days after the last dose; up to approximately 44 days for Parts A-D and up to 16 weeks for Part E
Parts A-D: Number of participants with clinically significant changes from baseline in clinical laboratory values
Timeframe: Baseline and up to approximately 1 month
Parts A-D: Number of participants with clinically significant changes from baseline in vital signs
Timeframe: Baseline and up to approximately 1 month
Parts A-D: Number of participants with clinically significant changes from baseline in cardiac conduction intervals
Timeframe: Baseline and up to approximately 1 month