Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection (HS627) and Perjeta ® in Healthy Male Subjects: a Randomized, Double-blind, Parallelity-controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)0-∞
研究概览
简要总结
This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male aged 18-
- •The body mass index is in the range of 19-26 kg/m2 (including thecritical value). The weight is 50 kg-80kg.
- •The subjects have no family planning within 3 months and could select contraceptive method
- •The subjects who have signed the informed consent and are able to complete the experiment according to the trial protocol.
- •Echocardiography showed left ventricular ejection fraction (LVEF) > 50% ,which two weeks before administration of experimental drug.
排除标准
- •The subjects with a history of malignant tumor.
- •The subjects who has received any live vaccine within 6 months prior to signing the informed consent.
- •The subjects who has upper respiratory tract infection or other acute infections within the previous 2 weeks of screening.
- •The subjects who had undergone surgery within 2 months prior to signing the informed consent.
- •Anti-drug antibody (ADA) detection positive.
- •Previous treatment with any antibody targeting the HER2 receptor or Those who have used monoclonal antibodies within 6 months prior to signing the informed consent.
研究组 & 干预措施
recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)
干预措施: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) (Drug)
Perjeta ®
干预措施: Perjeta ® (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 150 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 150 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Peak Plasma Concentration (Cmax)
时间窗: 150 days
Evaluation of Peak Plasma Concentration (Cmax)
次要结局
- The total clearance(CL)(150 days)
- elimination half-life time(T1/2)(150 days)