NCT03131700撤回1 期
Phase I, Double Blind, Randomized, Parallel-Arm, Single-Dose, Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator (Avastin®, Roche) in Healthy Male Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- TRPHARM
- 主要终点
- Maximum plasma concentration
研究概览
简要总结
The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.
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 aged 18 to 55 years inclusive.
- •Adult healthy male subjects between 18.0 and 30.0 kg/m2 body mass index (inclusive) and body weight ≥ 60 kg and ≤ 100 kg (inclusive).
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- •Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- •Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- •Positive alcohol test at screening or baseline visits
研究组 & 干预措施
EU sourced Avastin®
Active Comparator
A single dose of Avastin® will be administered (IV) 5 mg/kg dose .
干预措施: Avastin® (Biological)
RPH-001
Experimental
A single dose of RPH-001 will be administered (IV) 5 mg/kg dose .
干预措施: RPH001 (Biological)
结局指标
主要结局
Maximum plasma concentration
时间窗: Until 100 days after administration
Cmax
Area under concentration-time curve from time zero to the last sampling time
时间窗: Until 100 days after administration
Area Under the Curve - AUC(0-t)
Area under concentration-time curve from time zero to infinity
时间窗: Until 100 days after administration
Area Under the Curve - AUC(0-∞)
次要结局
- Physical examination(Until 100 days after administration)
- Concentration-time profiles(Until 100 days after administration)
- Terminal elimination rate constant (λz)(Until 100 days after administration)
- Nature, frequency, severity and relationship to study drug of recorded adverse events(Until 100 days after administration)
- Heart rate(Until 100 days after administration)
- Body temperature(Until 100 days after administration)
- Neutralizing antibody (NAb)(Until 100 days after administration)
- Terminal elimination half-life (t½)(Until 100 days after administration)
- Volume of distribution at steady state (Vss)(Until 100 days after administration)
- Respiratory rate(Until 100 days after administration)
- Time to maximum concentration (Tmax)(Until 100 days after administration)
- ECG(Until 100 days after administration)
- Anti-drug-antibody (ADA)(Until 100 days after administration)
- Apparent volume of distribution (Vz)(Until 100 days after administration)
- Clearance (CL)(Until 100 days after administration)
- Blood Pressure(Until 100 days after administration)
- Oxygen saturation(Until 100 days after administration)
- Clinical laboratory tests(Until 100 days after administration)
研究者
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