drugset / Trial / NCT07554222

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

NCT07554222

Phase 1 Recruiting 160 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

A multicenter clinical study to evaluate the safety, PK characteristics, immunogenicity characteristics, and PD characteristics of IBI3013 in healthy trial participants and active non-segmental vitiligo trial participants and severe alopecia areata trial participants. The study is divided into 2 parts, with Part 1 involving healthy trial participants lasting up to 24 weeks, and Part 2 involving active non-segmental vitiligo trial participants and severe alopecia areata trial participants lasting up to 48 weeks.

Timeline

Start
2026-04-18
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Baricitinib Small molecule 2 mg Oral
Subject IBI3013 Monoclonal antibody Subcutaneous