NCT01931189已完成1 期
A Clinical Pharmacokinetics Study of NI-071
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
研究概览
简要总结
The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, clinical laboratory tests, etc.)
- •Body Mass Index (BMI) of 18.5 to 25.0 kg/m2, and a total body weight of 50 to 80 kg
排除标准
- •Subjects with a following past History or concomitant diseases
- •Chronic or recurrent infectious disease
- •Demyelinating disease
- •Congestive heart failure
- •lymphoproliferative disorder or myelodysplastic syndrome
- •Malignancy
- •Interstitial lung disease
- •Subjects with active or latent tuberculosis or history of tuberculosis
结局指标
主要结局
PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
时间窗: 8 weeks
次要结局
- Safety : Incidence of Adverse Events(8 weeks)
- Safety : Incidence of Anti-Drug Antibodies(ADA)(8 weeks)
- PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)(8 weeks)
研究者
研究点 (1)
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