Phase 1 Study of BBT001 Drug in Healthy Adults and Adults with Moderate to Severe Atopic Dermatitis Randomized, Blinded, Placebo-Controlled Single and Multiple Dose Trial

What this Trial Is About

Researchers are evaluating BBT001 in a Phase 1, randomized, triple-blinded, placebo-controlled study involving healthy volunteers and adults with moderate to severe Atopic Dermatitis AD. This study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity of BBT001 compared to placebo. It includes two parts Part A with single ascending doses in healthy volunteers and Part B with multiple ascending doses in patients with AD. In Part A, healthy volunteers receive a single dose of either BBT001 or placebo in sequential ascending dose cohorts. In Part B, patients with moderate to severe AD receive seven repeated doses of either BBT001 or placebo. Each part follows a blinded and randomized design to evaluate the effects of the drug and placebo separately. Participants will be monitored for adverse events, changes in vital signs, blood parameters, physical exams, and electrocardiograms up to 141 days Part A or 169 days Part B after the first dose. Pharmacokinetic parameters and immunogenicity are also assessed during this period. The total study duration for participants includes screening, dosing, and extended follow-up to evaluate safety and clinical activity.

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)