Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-05280014 And Trastuzumab Sourced From US And EU Administered To Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Pharmacokinetic parameters Area-Under-the-Curve (AUC) and Maximal Concentration (Cmax) of PF-05280014 compared to trastuzumab-EU.
研究概览
简要总结
In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (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-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability, and immunologic response also will 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
- Male
- 接受健康志愿者
- 是
入选标准
- •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 30.5 kg/m2 and a total body weight > 50 kg (110 lbs).
- •Male subjects must agree that they and their female spouse/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential.
- •Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, or clinical findings at screening excluding untreated, asymptomatic seasonal allergies at time of dosing.
- •Clinically significant abnormalities in laboratory test results.
- •Previous exposure to a monoclonal antibody or current use of other biologics.
- •History of allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
- •Use of prescription or non prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
结局指标
主要结局
Pharmacokinetic parameters Area-Under-the-Curve (AUC) and Maximal Concentration (Cmax) of PF-05280014 compared to trastuzumab-EU.
时间窗: Day 1 - Day 71
Pharmacokinetic parameters Area-Under-the-Curve (AUC) and Maximal Concentration (Cmax) of PF-05280014 compared to trastuzumab-US.
时间窗: Day 1 - Day 71
Pharmacokinetic parameters Area-Under-the-Curve (AUC) and Maximal Concentration (Cmax) of trastuzumab-EU to trastuzumab-US.
时间窗: Day 1 - Day 71
次要结局
- Incidence of anti-trastuzumab antibodies (ADAs), including neutralizing antibodies (Nab).(Day 1 - LSLV or Day 71 whichever occurs later)
- Pharmacokinetic parameters Maximal Concentration (Cmax) and Area-Under-the-Curve (AUC) for the combined groups of trastuzumab-US and trastuzumab EU.(Day 1 - Day 71)