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RECRUITING
NCT07554222
PHASE1

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

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-04-18

Completion Date

2028-12-31

Last Updated

2026-04-28

Healthy Volunteers

Yes

Interventions

DRUG

placebo

placebo

DRUG

Baricitinib tablets

Baricitinib tablets

DRUG

IBI3013

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

Locations (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China