Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 362
- 试验地点
- 15
- 主要终点
- maximal serum concentration (Cmax)
研究概览
简要总结
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
- •Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs).
- •Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
结局指标
主要结局
maximal serum concentration (Cmax)
时间窗: Day 1 - Day 50
maximal serum concentration (Cmax)
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)
时间窗: 0-336 hours
area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]
时间窗: Day 1 - Day 50
AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)
AUC extrapolated to infinity (AUC0inf)
时间窗: Day 1 - Day 50
AUC extrapolated to infinity (AUC0inf)
次要结局
- Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters(Day 1- Day 71)
- Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)(Day 1- Day 71)
- maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US(Day 1 - Day 50)
- area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US(0-336 hours)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US(Day 1 - Day 50)
- AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US(Day 1 - Day 50)
- time to reach the maximum concentration (Tmax)(Day 1 - Day 50)
- Apparent clearance (CL/F)(Day 1 - Day 50)
- Apparent volume of distribution (Vz/F)(Day 1 - Day 50)
- Terminal half-life (T1/2)(Day 1 - Day 50)