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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

ConditionsHealthyActive Non-segmental VitiligoSevere Alopecia Areata
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • placebo

    Drug

    placebo

  • Baricitinib tablets

    Drug

    Baricitinib tablets

  • IBI3013

    Drug

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

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: Baricitinib tabletsActive comparator 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Group C: IBI3013Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of participants with at least one treatment-emergent adverse event

Time frame
up to 24 weeks
2

Part 1: Number of participants with at least one Serious treatment-emergent adverse event

Time frame
up to 24 weeks
3

Part 2: Number of participants with at least one treatment-emergent adverse event

Time frame
up to 48 weeks
4

Part 2: Number of participants with at least one Serious treatment-emergent adverse event

Time frame
up to 48 weeks

Secondary outcomes

1

Part 1: Cmax following a single dose of IBI3013.

Time frame
up to 24 weeks
2

Part 1: Tmax following a single dose of IBI3013.

Time frame
up to 24 weeks
3

Part 1: AUC following a single dose of IBI3013.

Time frame
up to 24 weeks
4

Part 1: Cmin following a single dose of IBI3013.

Time frame
up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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