NCT07554222招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Part 1: Number of participants with at least one treatment-emergent adverse event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
- •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;
- •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;
- •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.
排除标准
- •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;
- •All participants: History of drug abuse, drug dependence, or positive drug screening results during the screening period within 12 months;
- •All participants: Pregnant or lactating women;
- •All participants: Coexisting diseases at screening or previously, deemed unsuitable for clinical trials;
- •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;
- •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;
- •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;
- •Severe alopecia areata trial participants: Previously received oral JAK inhibitors with poor response;
- •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.
研究组 & 干预措施
Baricitinib tablets
Active Comparator
oral, 2mg, once daily
干预措施: Baricitinib tablets (Drug)
placebo
Placebo Comparator
subcutaneous injection/intravenous infusion,single or multiple dosing
干预措施: placebo (Drug)
IBI3013
Experimental
subcutaneous injection/intravenous infusion,single or multiple dosing
干预措施: IBI3013 (Drug)
结局指标
主要结局
Part 1: Number of participants with at least one treatment-emergent adverse event
时间窗: up to 24 weeks
Part 1: Number of participants with at least one Serious treatment-emergent adverse event
时间窗: up to 24 weeks
Part 2: Number of participants with at least one treatment-emergent adverse event
时间窗: up to 48 weeks
Part 2: Number of participants with at least one Serious treatment-emergent adverse event
时间窗: up to 48 weeks
次要结局
- Part 1: Cmax following a single dose of IBI3013.(up to 24 weeks)
- Part 1: Tmax following a single dose of IBI3013.(up to 24 weeks)
- Part 1: AUC following a single dose of IBI3013.(up to 24 weeks)
- Part 1: Cmin following a single dose of IBI3013.(up to 24 weeks)
- Part 1: CL/F or CL following a single dose of IBI3013.(up to 24 weeks)
- Part 1: Vd/F or Vd following a single dose of IBI3013.(up to 24 weeks)
- Part 1: T1/2 following a single dose of IBI3013.(up to 24 weeks)
- Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013.(up to Day85)
- Part 2: Cmax following multiple doses of IBI3013.(up to 48 weeks)
- Part 2: Tmax following multiple doses of IBI3013.(up to 48 weeks)
- Part 2: AUC following multiple doses of IBI3013.(up to 48 weeks)
- Part 2: Cmin following multiple doses of IBI3013.(up to 48 weeks)
- Part 2: CL/F following multiple doses of IBI3013.(up to 48 weeks)
- Part 2: Vd/F following multiple doses of IBI3013.(up to 48 weeks)
- Part 2: T1/2 following multiple doses of IBI3013.(up to 48 weeks)
- Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013.(up to 28 weeks)
研究者
研究点 (1)
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