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

NCT07554222
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
160
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Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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Start date
2026-04-18
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Number of sites
1
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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.
clinicaltrials.gov
Short 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
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-12-31
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First posted
2026-04-28
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Registry last updated
2026-04-28
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Primary completion date
2027-12-31
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Start date
2026-04-18
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Participants
160
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Participant count basis
Estimated
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Planned participants
160
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Protocol amendments
0
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07554222
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ClinicalTrials.gov ID
NCT07554222
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Participants
Sources for study design
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  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

    Timeframe: up to 48 weeks

  1. Part 1: Cmax following a single dose of IBI3013.

    Timeframe: up to 24 weeks

  2. Part 1: Tmax following a single dose of IBI3013.

    Timeframe: up to 24 weeks

  3. Part 1: AUC following a single dose of IBI3013.

    Timeframe: up to 24 weeks

  4. Part 1: Cmin following a single dose of IBI3013.

    Timeframe: up to 24 weeks

  5. Part 1: CL/F or CL following a single dose of IBI3013.

    Timeframe: up to 24 weeks

  6. Part 1: Vd/F or Vd following a single dose of IBI3013.

    Timeframe: up to 24 weeks

  7. Part 1: T1/2 following a single dose of IBI3013.

    Timeframe: up to 24 weeks

  8. Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013.

    Timeframe: up to Day85

  9. Part 2: Cmax following multiple doses of IBI3013.

    Timeframe: up to 48 weeks

  10. Part 2: Tmax following multiple doses of IBI3013.

    Timeframe: up to 48 weeks

  11. Part 2: AUC following multiple doses of IBI3013.

    Timeframe: up to 48 weeks

  12. Part 2: Cmin following multiple doses of IBI3013.

    Timeframe: up to 48 weeks

  13. Part 2: CL/F following multiple doses of IBI3013.

    Timeframe: up to 48 weeks

  14. Part 2: Vd/F following multiple doses of IBI3013.

    Timeframe: up to 48 weeks

  15. Part 2: T1/2 following multiple doses of IBI3013.

    Timeframe: up to 48 weeks

  16. Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013.

    Timeframe: up to 28 weeks

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
Yes

  1. Part 1 - Healthy trial participants: Understand and voluntarily sign the informed consent form;
  2. Part 1 - Healthy trial participants: Age between 18-45 years (inclusive), male or female;
  3. Part 1 - Healthy trial participants: Weight between 50-120 kg (inclusive), and BMI between 17.0-28.0 kg/m2 (inclusive);
  4. Part 2 - Active non-segmental vitiligo trial participants: 18-65 years old (inclusive), male;
  5. Part 2 - Active non-segmental vitiligo trial participants: Diagnosed with non-segmental vitiligo for ≥3 months and <2 years;
  6. 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;
  7. Part 2 - : Male participants of reproductive potential agree to use highly effective contraception and avoid sperm donation for 6 months after the last dose.
  8. Part 2 - Severe alopecia areata trial participants: 18-60 years old (inclusive), male;
  9. Part 2 - Severe alopecia areata trial participants: Meet the following severe alopecia areata criteria: a) SALT ≥50% (i.e., AA-IGA 3-4 grade) b) No spontaneous remission in the past 6 months (spontaneous remission defined as SALT reduction by ?10 points) c) Current duration of severe alopecia areata ≥6 months and <4 years;
  10. All participants: Participants of reproductive potential agree to use highly effective contraception and avoid sperm or egg donation for 6 months after the last dose.

  1. All participants: Those who are allergic to any component of IBI3013;
  2. All participants: Those who cannot tolerate subcutaneous injection;
  3. 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;
  4. All participants: Donated blood or lost ≥400 mL of blood within 3 months before screening;
  5. All participants: History of herpes zoster or disseminated herpes simplex (single episode), or recurrent (more than one episode) localized herpes zoster;
  6. All participants: Known history of active tuberculosis or clinical manifestations suggestive of tuberculosis, or positive interferon-gamma release assay unsuitable for participation;
  7. 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;
  8. All participants: Received specific treatment within the time frame specified in the protocol, or participated in other investigational drug studies within the specified time;
  9. All participants: History of drug abuse, drug dependence, or positive drug screening results during the screening period within 12 months;
  10. All participants: Pregnant or lactating women;
  11. All participants: Coexisting diseases at screening or previously, deemed unsuitable for clinical trials;
  12. Active non-segmental vitiligo/Severe alopecia areata trial participants: Previous or coexisting diseases, which may affect the efficacy or safety evaluation of the study as assessed by the investigator;
  13. Active non-segmental vitiligo trial participants: Coexisting segmental, undetermined type, or mixed-type vitiligo, or other skin pigmentation disorders, or other skin-related abnormalities that may affect the assessment of the study;
  14. Severe alopecia areata trial participants: Currently diagnosed with primary diffuse AA or ophiasis AA; or other types of hair loss that may interfere with AA evaluation;
  15. Severe alopecia areata trial participants: Previously received oral JAK inhibitors with poor response; 16. Severe alopecia areata trial participants: Acute myocardial infarction, unstable ischemic heart disease, stroke, chronic heart failure (NYHA class III/IV) within 12 weeks prior to screening; or previous history of deep vein thrombosis, or high risk of deep vein thrombosis as assessed by the investigator; or severe neuropsychiatric disorder, deemed unsuitable for the study by the investigator.
Sources for eligibility
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  • Huashan Hospital, Fudan UniversityShanghai, ChinaRecruiting
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)