Bambusa Therapeutics
This is a Phase 1, randomized, blinded, placebo controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT001 in healthy volunteers (HVs) and in adult patients with atopic dermatitis. BBT001 is a drug candidate being developed for the treatment of atopic dermatitis.
Key Inclusion Criteria 1. Negative pregnancy tests for women of childbearing potential. 2. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit. 3. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers. 4. Adequate contraception use (for men and women of childbearing potential). Key Inclusion Criteria (Parts A, B, and D) 1. Age of 18-65 years. 2. Body mass index of 18 to 32 kg/m², weight capped at 120 kg. 3. No clinically significant abnormalities or history of relevant diseases. Key Inclusion Criteria (Parts C and E only) 1. Age of 18-7…
BBT001 will be administered
Placebo will be administered