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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInnovent Biologics (Suzhou) Co. Ltd.

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

Treatment groups

160 Participants
are divided into 3 treatment groups