Phase 1 Study to Test Safety and Effects of BG-A3004 in Healthy Adults and Adults with Immune-Mediated Skin Diseases

What this Trial Is About

Researchers are conducting a first-in-human study to evaluate BG-A3004 in both healthy adults and patients with immune-mediated skin diseases. The study aims to assess safety, tolerability, how the body processes the drug pharmacokinetics, immune response immunogenicity, and drug effects pharmacodynamics after single and multiple doses. The research includes healthy participants and patients with conditions like alopecia areata, cutaneous lichen planus, and nonsegmental vitiligo. Participants will be divided into groups receiving different dose levels of BG-A3004 or matching placebo. Healthy participants Part A will receive a single subcutaneous dose, while patients with skin diseases Part B will receive multiple doses. Dose levels will increase sequentially to study effects. The treatment duration is one dose for healthy participants and four doses for patients. After the last dose, safety follow-up will continue for 168 days. During the study, participants will undergo medical evaluations including physical exams, lab tests, and cardiac monitoring to ensure safety. Researchers will track adverse events and measure drug concentrations over up to 24 weeks for healthy participants and 36 weeks for patients. Immunogenicity and pharmacodynamic responses will be monitored. The total study duration is about three years, covering treatment, follow-up, and observation periods.

A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases