Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Double-blind, Single Dose, Parallel-arm, Active Comparator Clinical Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 3
- 主要终点
- Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®
研究概览
简要总结
Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 695501
Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501
干预措施: BI 695501 (Drug)
adalimumab-EU source
Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source
干预措施: adalimumab-EU source (Drug)
adalimumab-US source
Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-US source
干预措施: adalimumab-US source (Drug)
结局指标
主要结局
Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®
时间窗: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®. Abbreviation used: Pharmacokinetics (PK).
Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®
时间窗: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Area under the concentration time curve from time zero to last measurable concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®
时间窗: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Maximum concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®.
次要结局
- AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®(at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing)
- AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®(at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312 hours post dosing)
- AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®(at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480 hours post dosing)
- AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®(at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648 hours post dosing)
- AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira®(at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032 hours post dosing)
- AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira®(at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.)
- Number (Proportion) of Subjects With Drug Related Adverse Events(Day 1 through Day 71)