A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 141
- 试验地点
- 3
- 主要终点
- AUC0-inf
研究概览
简要总结
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects
详细描述
This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141 subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin, or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by 15 weeks during which the PK, safety, and immunogenicity measurements will be made. The randomization will be stratified by body weight and site.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 19 and 55 years, both inclusive
- •Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥ 50 kg
排除标准
- •Subject is a female.
- •Clinically significant allergic reactions, hypersensitivity
- •A disease classed as significant by the Investigator
- •Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant traumatic injury
- •Any malignancy
- •Undergone treatment with an investigational drug or participated in another clinical trial
- •Plans to father a child or donates sperms
研究组 & 干预措施
CT-P16
CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects
干预措施: CT-P16 (Drug)
EU-approved Avastin
EU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
干预措施: EU-approved Avastin (Drug)
US-licensed Avastin
US-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
干预措施: US-licensed Avastin (Drug)
结局指标
主要结局
AUC0-inf
时间窗: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Area under the concentration-time curve from time zero to infinity
Cmax
时间窗: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Maximum Serum Concentration (Cmax)
AUC0-last
时间窗: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
次要结局
- Additional Pharmacokinetics (Time to Cmax)(pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI)
- Number of Participants With Anti-Drug Antibody Positive(up to 15 weeks)