RecruitingPhase 1NCT07554222

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

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


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

160 participants

Start Date

Apr 18, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Baricitinib tablets, a drug called IBI3013, and others for people with active non-segmental vitiligo, healthy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGplacebo

placebo

DRUGBaricitinib tablets

Baricitinib tablets

DRUGIBI3013

Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection


Locations(1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT07554222


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