A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Trastuzumab (SB3, EU Sourced Herceptin® and US Sourced Herceptin®) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) 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
- Double (Participant, 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
- •Have a body weight between 60.0 and 94.9 kg and a body mass index between 18.0 and 29.9 kg/m², inclusive.
排除标准
- •history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or significant allergic disease excluding mild asymptomatic allergies.
- •history of and/or current cardiac disease
- •previously received any monoclonal antibody or fusion protein.
- •history of cancer including lymphoma, leukaemia and skin cancer.
- •Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
- •intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.
研究组 & 干预措施
EU sourced Herceptin®
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
干预措施: EU sourced Herceptin® (Biological)
US sourced Herceptin®
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
干预措施: US sourced Herceptin® (Biological)
SB3
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
干预措施: SB3 (Biological)
结局指标
主要结局
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
时间窗: 57 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
时间窗: 57 days
Maximum Serum Concentration (Cmax)
时间窗: 57 days
次要结局
- Time to Cmax (Tmax)(57 days)