Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single-dose Administration of IBI3013 in Healthy Adults and Multiple-dose Administration in Active Non-segmental Vitiligo and Severe Alopecia Areata Patients - Randomized, Double-blind, Placebo-controlled, Dose-escalation Study

What this Trial Is About

Researchers are evaluating the safety, how the body processes, and the immune response to a drug called IBI3013 in healthy adults and in adults with active non-segmental vitiligo or severe alopecia areata. This Phase 1 study aims to understand these effects through two parts: Part 1 with healthy participants lasting up to 24 weeks, and Part 2 with vitiligo and alopecia areata participants lasting up to 48 weeks. The study is sponsored by Innovent Biologics (Suzhou) Co. Ltd. Participants receive different treatments depending on their study part. In Part 1, healthy volunteers receive a single dose of IBI3013 by injection or infusion, or a placebo, and take oral tablets once daily. In Part 2, patients with vitiligo or alopecia areata receive multiple doses of IBI3013 or placebo by injection or infusion. The study compares these treatments to assess how the drug is absorbed and processed in the body and monitors the immune response over time. During the study, participants will be closely monitored through regular visits up to 24 or 48 weeks depending on their group. Researchers will track any side effects, serious events, and measure drug levels in the body. They will also test for immune reactions to the drug. Participants will have various lab tests, vital sign checks, and safety assessments. The study ensures monitoring of treatment safety and how well participants tolerate the drug throughout the study period.

Study to Evaluate the Safety, Tolerability and How IBI3013 is Taken up and Processed by the Body in Healthy Volunteers After Single-dose Administration, and in Non-segmental Vitiligo Patients and Alopecia Areata Patients After Multiple-dose Administration