Actively Recruiting
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
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-04-28
160
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part 1 healthy participants must understand and voluntarily sign informed consent.
- Part 1 healthy participants aged 18-45 years, male or female.
- Part 1 healthy participants weighing 50-120 kg with BMI between 17.0 and 28.0 kg/m2.
- Part 2 active non-segmental vitiligo male participants aged 18-65 years.
- Part 2 active non-segmental vitiligo diagnosed for at least 3 months but less than 2 years.
- Part 2 active non-segmental vitiligo with total affected body surface area 3-50%, facial affected area at least 0.5%, T-VASI 3-50, F-VASI at least 0.5, and at least one active lesion.
- Part 2 male participants of reproductive potential agree to use highly effective contraception and avoid sperm donation for 6 months after last dose.
- Part 2 severe alopecia areata male participants aged 18-60 years.
- Part 2 severe alopecia areata with SALT score at least 50%, no spontaneous remission in past 6 months, and disease duration between 6 months and less than 4 years.
- All participants of reproductive potential agree to use highly effective contraception and avoid sperm or egg donation for 6 months after last dose.
You will not qualify if you...
- Allergy to any component of IBI3013.
- Unable to tolerate subcutaneous injection.
- Live or attenuated vaccine within 30 days prior to randomization or planned during study until 3 months after last dose.
- Blood donation or loss of 400 mL or more blood within 3 months before screening.
- History of herpes zoster or disseminated herpes simplex or recurrent localized herpes zoster.
- Active tuberculosis or suggestive clinical manifestations or positive interferon-gamma release assay unsuitable for participation.
- Abnormal vital signs, serum virology, lab tests, ECG, or other exams with clinical significance deemed unsuitable.
- Received specified treatments or participated in other investigational drug studies within specified times.
- History of drug abuse, dependence, or positive drug screening within 12 months.
- Pregnant or lactating women.
- Coexisting diseases deemed unsuitable for clinical trials.
- For vitiligo participants: segmental, undetermined, mixed-type vitiligo, or other skin pigmentation disorders or abnormalities affecting assessment.
- For alopecia areata participants: primary diffuse AA or ophiasis AA or other hair loss types interfering with evaluation.
- For alopecia areata participants: prior poor response to oral JAK inhibitors.
- Recent serious cardiac events or high risk of deep vein thrombosis, or severe neuropsychiatric disorder deemed unsuitable by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
juan chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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