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临床试验/NCT05995691
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

Amgen0 个研究点目标入组 179 人开始时间: 2014年11月24日最近更新:
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

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

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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