A Phase I, Randomized, Double-Blind, Parallel-Group, Single-Dose Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of MSB11022, US-Reference Product, and EU-Reference Medicinal Product (Humira®) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 237
- 主要终点
- Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-last])
研究概览
简要总结
This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal Product (RMP) (Humira®) in healthy subjects.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects and healthy female subjects of non-childbearing potential aged 18 to 55 years, inclusive.
- •Other protocol defined inclusion criteria could apply.
排除标准
- •Concurrent or history infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection.
- •Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay.
- •Concurrent or history of demyelinating disease (multiple sclerosis, etc.).
- •Concurrent or history of congestive cardiac failure.
- •Concurrent or history of allergic symptoms such as asthma bronchial, drug-induced rash, and urticaria, which, in the judgment of the investigator, may affect participation in this clinical study.
- •Concurrent or history of cardiac, hepatic, renal, gastrointestinal, respiratory, and/or hematological function disorders, which, in the judgment of the investigator or any of the sub investigators, may affect participation in this clinical study.
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
MSB11022
干预措施: MSB11022 (Drug)
US-licensed Humira
干预措施: US-licensed Humira (Drug)
EU-approved Humira
干预措施: EU-approved Humira (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-last])
时间窗: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours
Primary: Area Under the Concentration-Time Curve From time Zero Extrapolated to Infinity (AUC [0-inf])
时间窗: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours
Maximum Observed Serum Concentration (Cmax)
时间窗: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours
次要结局
- Apparent Total Clearance (CL/F)(Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours)
- Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Death(Baseline up to Day 71)
- Number of Subjects With Injection Site Reactions(Baseline up to Day 71)
- Terminal Half-Life (t1/2)(Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours)
- Number of Subjects With Anti-drug Antibodies (ADA) for MSB11022(Day 1 up to Day 71)
- Time to Reach Maximum Observed Serum Concentration (Tmax)(Pre-dose 0 hour, post-dose 4, 8 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours)
- Apparent Volume of Distribution During the Terminal Phase (Vz/F)(Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours)