A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Maximum Serum Concentration (Cmax)
研究概览
简要总结
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab
详细描述
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 body weight between 65.0-90.0 kg (inclusive) and body mass index between 20.0-29.9 kg/m2 (inclusive)
排除标准
- •Have a history of hypersensitivity or allergic reactions to bevacizumab or to any of the excipients
- •Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric, or allergic disease excluding mild asymptomatic seasonal allergies
- •Have a history of arterial thromboembolic events including cerebrovascular accidents, transient ischaemic attacks, and myocardial infarction
- •Have a history of and/or current cardiac disease
- •Have previously been exposed to vascular endothelial growth factor (VEGF) antibody, any other antibody, or protein targeting the VEGF receptor
- •Have a history of cancer including lymphoma, leukaemia, and skin cancer.
- •Have received live vaccine(s) within 30 days prior to Screening visit or who will require a vaccine(s) between Screening and the end of study visit
- •Have taken medication with a half-life of > 24 hours within 30 days or 10 half-lives of the medication prior to the IP administration
研究组 & 干预措施
EU Sourced Avastin®
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
干预措施: EU sourced Avastin® (Biological)
US Sourced Avastin®
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
干预措施: US Sourced Avastin® (Biological)
SB8
SB8, single dose of 3 mg/kg, IV infusion
干预措施: SB8 (Biological)
结局指标
主要结局
Maximum Serum Concentration (Cmax)
时间窗: 0 to 2016 hours after start of infusion
0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
时间窗: 0 to 2016 hours after start of infusion
0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
时间窗: 0 to 2016 hours after start of infusion
0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.
次要结局
- Time to Reach Cmax (Tmax)(0 to 2016 hours after start of infusion)