Phase 1 Study of BBT001 to Test Safety and Effects in Healthy Adults and Adults With Moderate to Severe Atopic Dermatitis

What this Trial Is About

Researchers are studying BBT001, a drug candidate for treating moderate to severe atopic dermatitis AD, in a Phase 1 randomized, double-blinded, placebo-controlled trial involving healthy volunteers and adult patients with AD. The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT001. Participants will receive either a single or multiple ascending doses of BBT001 or placebo. Healthy volunteers will receive single and multiple doses, while adult patients with moderate to severe AD will receive multiple doses. The study includes several parts A, B, C, D, and E with different dosing regimens to assess these effects. Throughout the study, participants will be monitored for adverse events, changes in blood parameters, vital signs, physical exams, and ECG readings for up to 169 days after the first dose. Pharmacokinetic and immunogenicity measures will also be collected at specified time points. The total duration of monitoring varies by study part but can last up to approximately 24 weeks post-dose.

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