A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
Trial Parameters
Brief Summary
This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
Eligibility Criteria
Key Inclusion Criteria ( Part A and B): 1. Age of 18-65 years. 2. Body mass index between 18-28 kg/m², capped at 120 kg. 3. Negative pregnancy tests for women of childbearing potential. 4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit. 5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers. 6. Adequate contraception use (for men and women of childbearing potential). 7. No clinically significant abnormalities or history of relevant diseases. Key Inclusion Criteria (Part B only): 1. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable. 2. Moderate to severe atopic dermatitis 3. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3 4. Atopic lesions cover ≥10% of body surface area (BSA) 5. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization. 6. Eczema A