NCT02927353已完成1 期
A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects
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
- 180
- 主要终点
- Area under the serum concentration-time curve (AUC) from 0 to final sampling time point
研究概览
简要总结
To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male 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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male adults;
- •The Body Mass Index (BMI) of the subjects must be from 17.6 to 26.4 kg/m2 at the time of the screening test;and
- •Subjects must take a screening test within the 4 weeks before the date of administration of the study drug; subjects must take a screening test before the date of administration of the study drug and exhibit no clinically abnormal findings in the judgment of the investigator or any of the subinvestigators
排除标准
- •Concurrent or history of potentially fatal 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 or any of the subinvestigators, may affect participation in this clinical study; or
- •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 subinvestigators, may affect participation in this clinical study
研究组 & 干预措施
DMB-3113
Experimental
adalimumab biosimilar
干预措施: DMB-3113 (Drug)
adalimumab
Active Comparator
adalimumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
Area under the serum concentration-time curve (AUC) from 0 to final sampling time point
时间窗: Day 1 to Day 71
AUC from 0 to infinity
时间窗: Day 1 to Day 71
Maximum serum concentration (Cmax)
时间窗: Day 1 to Day 71
次要结局
- Mean residence time (MRT) from 0 to final sampling time point(Day 1 to Day 71)
- MRT from 0 to infinity(Day 1 to Day 71)
- Elimination half life (t1/2)(Day 1 to Day 71)
- AUC from 0 to the last measurable concentration(Day 1 to Day 71)
- Observed clearance (CL/F)(Day 1 to Day 71)
- Observed volume of distribution (V/F)(Day 1 to Day 71)
- Time to reach the peak concentration (tmax)(Day 1 to Day 71)
- Elimination rate constant (kel)(Day 1 to Day 71)
- Incidence of adverse events(Day 1 to Day 71)
研究者
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