NCT02015156已完成1 期
Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 2-Arm, Safety Study Of PF-05280014 And Trastuzumab Sourced From The US Administered To Healthy Male Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 162
- 试验地点
- 3
- 主要终点
- Incidence of body temperature greater than or equal to 38.0 degrees Celsius
研究概览
简要总结
This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.
详细描述
Safety evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Body Mass Index (BMI) of 17.5 to 30.5 kg^m2; and a total body weight >50 kg (110 lbs).
- •Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
- •Subjects who have previously been exposed to a biologic agent (other than a HER2 inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Previous exposure to an anti-HER2 antibody.
- •History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
结局指标
主要结局
Incidence of body temperature greater than or equal to 38.0 degrees Celsius
时间窗: within 24 hours
次要结局
- Timing of pyrexia(within 24 hours)
- Seriousness of pyrexia(within 24 hours)
- Relationship of study therapy to pyrexia(within 24 hours)
- Severity of pyrexia(within 24 hours)
- Incidence of pyrexia(within 24 hours)
- Incidence of body temperature greater than or equal to 38.0°C and/or use of concomitant treatment associated with fever suppression(within 24 hours)
研究者
研究点 (3)
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