Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)
研究概览
简要总结
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.
排除标准
- •Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.
研究组 & 干预措施
C
Adalimumab-US
干预措施: Humira (adalimumab-US) (Biological)
B
Adalimumab-EU
干预措施: Humira (adalimumab-EU) (Biological)
A
PF-06410293
干预措施: PF-06410293 (Biological)
结局指标
主要结局
Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)
时间窗: Day 1 - Day 43
Maximum Observed Serum Concentration (Cmax)
时间窗: Day 1 - Day 43
Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)
时间窗: Day 1 - Day 43
次要结局
- Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)(Day 1 - Day 71)
- Time to Reach Maximum Observed Serum Concentration (Tmax)(Day 1- Day 43)
- Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing(Day 1- Day 43)
- Systemic Clearance (CL)(Day 1- Day 43)
- Serum Decay Half-Life (t1/2)(Day 1- Day 43)