About this trial
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.
Eligibility criteria
Qualifiers
Part 1 - Healthy trial participants: Understand and voluntarily sign the informed consent form;
Part 1 - Healthy trial participants: Age between 18-45 years (inclusive), male or female;
Part 1 - Healthy trial participants: Weight between 50-120 kg (inclusive), and BMI between 17.0-28.0 kg/m2 (inclusive);
Part 2 - Active non-segmental vitiligo trial participants: 18-65 years old (inclusive), male;
Disqualifiers
All participants: Those who are allergic to any component of IBI3013;
All participants: Those who cannot tolerate subcutaneous injection;
All participants: History of live or attenuated live vaccine within 30 days prior to randomization, or expected to receive such vaccines during the study period until 3 months after the last dose of the investigational drug;
All participants: Donated blood or lost ≥400 mL of blood within 3 months before screening;
Trial design
Treatments tested in this trial
- placebo
- Baricitinib tablets
- IBI3013