NCT05995691已完成1 期
A Randomized, Single-blind, Single-dose, 2-Arm, Parallel-group Study to Determine the Pharmacokinetic Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese 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
- 发起方
- Amgen
- 入组人数
- 179
- 主要终点
- Cmax of Adalimumab
研究概览
简要总结
The primary objective of this study is to determine the bioequivalence of ABP 501 (subcutaneous [SC] injection) compared to adalimumab (SC injection) as assessed principally by the area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf), and maximum observed serum concentration (Cmax) in Japanese participants.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 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
ABP 501
Experimental
Participants will receive a single dose of ABP 501
干预措施: ABP 501 (Drug)
Adalimumab
Active Comparator
Participants will receive a single dose of adalimumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
Cmax of Adalimumab
时间窗: Day 1 to Day 63
AUCinf of ABP 501
时间窗: Day 1 to Day 63
Cmax of ABP 501
时间窗: Day 1 to Day 63
AUCinf of Adalimumab
时间窗: Day 1 to Day 63
次要结局
- t1/2 of Adalimumab(Day 1 to Day 63)
- Time at Which the Maximum Observed Serum Concentration is Observed (Tmax) of ABP 501(Day 1 to Day 63)
- Tmax of Adalimumab(Day 1 to Day 63)
- Area Under the Serum Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUClast) of ABP 501(Day 1 to Day 63)
- AUClast of Adalimumab(Day 1 to Day 63)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Day 1 to Day 63)
- Number of Participants With Anti-drug Antibodies (ADA)(Day 1 to Day 63)
- Terminal Phase Elimination Half-life (t1/2) of ABP 501(Day 1 to Day 63)
研究者
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