Study to Evaluate the Safety, Tolerability and How IBI3013 is Taken up and Processed by the Body … (NCT07554222) | Clinical Trial Compass
RecruitingPhase 1
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
China160 participantsStarted 2026-04-18
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Number of participants with at least one treatment-emergent adverse event
Timeframe: up to 24 weeks
2
Part 1: Number of participants with at least one Serious treatment-emergent adverse event
Timeframe: up to 24 weeks
3
Part 2: Number of participants with at least one treatment-emergent adverse event
Timeframe: up to 48 weeks
4
Part 2: Number of participants with at least one Serious treatment-emergent adverse event
. 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;
Exclusion criteria
. 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;
. All participants: History of herpes zoster or disseminated herpes simplex (single episode), or recurrent (more than one episode) localized herpes zoster;
. All participants: Known history of active tuberculosis or clinical manifestations suggestive of tuberculosis, or positive interferon-gamma release assay unsuitable for participation;
. All participants: Abnormal vital signs, serum virology tests, laboratory tests, ECG, or other examinations with clinical significance, and deemed unsuitable for the study by the investigator;
. All participants: Received specific treatment within the time frame specified in the protocol, or participated in other investigational drug studies within the specified time;