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临床试验/NCT03014947
NCT03014947已完成1 期

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

Fresenius Kabi SwissBioSim GmbH0 个研究点目标入组 237 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: MSB11022 (Drug)

US-licensed Humira

Active Comparator

干预措施: US-licensed Humira (Drug)

EU-approved Humira

Active Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

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