Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax)
研究概览
简要总结
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
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 female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- •Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight >50kg (110 lbs).
排除标准
- •Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Previous exposure to a monoclonal antibody, or current use of other biologics.
- •History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
- •History of tuberculosis (TB) or a positive latent TB test at Screening.
研究组 & 干预措施
B = Infliximab-EU
干预措施: Remicade (Biological)
A = PF-06438179
干预措施: PF-06438179 (Biological)
C = Infliximab-US
干预措施: Remicade (Biological)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax)
时间窗: Day 1 - Day 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
时间窗: Day 1 - Day 57
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)
时间窗: Day 1 - Day 57
次要结局
- Volume of Distribution at Steady State (Vss)(Day 1 - Day 57)
- Systemic Clearance (CL)(Day 1 - Day 57)
- Terminal Disposition Half-Life (t1/2)(Day 1 - Day 57)
- Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)(Day 1 - LSLV or Day 85 whichever occurs later)