NCT02206867已完成1 期
A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers
LG Life Sciences0 个研究点目标入组 116 人开始时间: 2014年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 主要终点
- Maximum measured concentration of the analyte in serum
研究概览
简要总结
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •20-45 years old healthy males
- •Body mass index 19.0 ~ 28.0 kg/m2
排除标准
- •Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB
- •Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration
- •Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders
- •Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab)
- •Fever greater than 38.3℃ within a week prior to administration of study drug
- •Previous or current drug abuse
结局指标
主要结局
Maximum measured concentration of the analyte in serum
时间窗: 0 to 65 days
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity
时间窗: 0 to 65 days
次要结局
未报告次要终点
研究者
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