Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single-dose Administration of IBI3013 in Healthy Adult Trial Participants and Multiple-dose Administration in Active Non-segmental Vitiligo Trial Participants and Severe Alopecia Areata Trial Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Study
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.
• 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;
• Part 2 - Active non-segmental vitiligo trial participants: Diagnosed with non-segmental vitiligo for ≥3 months and \<2 years;
• Part 2 - Active non-segmental vitiligo trial participants: Total affected BSA 3-50%, and facial affected BSA ≥ 0.5%; T-VASI 3-50 (inclusive), and F-VASI ≥0.5; ≥1 active lesion;
• Part 2 - : Male participants of reproductive potential agree to use highly effective contraception and avoid sperm donation for 6 months after the last dose.
• Part 2 - Severe alopecia areata trial participants: 18-60 years old (inclusive), male;
• Part 2 - Severe alopecia areata trial participants: Meet the following severe alopecia areata criteria: a) SALT ≥50% (i.e., AA-IGA 3-4 grade) b) No spontaneous remission in the past 6 months (spontaneous remission defined as SALT reduction by ?10 points) c) Current duration of severe alopecia areata ≥6 months and \<4 years;
⁃ All participants: Participants of reproductive potential agree to use highly effective contraception and avoid sperm or egg donation for 6 months after the last dose.