A Randomized, Double-blind, Single-dose, Parallel-group Study Comparing Pharmacokinetic Characteristics, Safety , Tolerability and Immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in Healthy Chinese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Terminal elimination half-life（t1/2）
研究概览
简要总结
This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •Subjects aged 18 - 45 years
- •Subjects weighing ≥ 50.0 kg and ≤ 100.0 kg
- •Subjects with a body mass index (BMI) ≥ 19.0 and ≤ 26.0 kg/m2
排除标准
- •Subjects with evidence or history of clinically significant disease
- •Subjects with a history of previous cancer
- •Subjects with a history of hypertension, or abnormal blood pressure at screening/baseline measurements (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg confirmed by a repeat measurement on the same day)
- •Subjects with a history of blood donation 3 months before study drug infusion
- •Subjects with a history of exposure to antibodies 12 months before study drug infusion
- •Subjects with previous exposure to anti-VEGF therapy
研究组 & 干预措施
LY01008
Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).
干预措施: LY01008 (Drug)
Avastin
Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min).
干预措施: Avastin (Drug)
结局指标
主要结局
Terminal elimination half-life（t1/2）
时间窗: From baseline to Day 99
Apparent volume of distribution（Vd）
时间窗: From baseline to Day 99
Maximum (peak) plasma concentration（Cmax）
时间窗: From baseline to Day 99
Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）
时间窗: From baseline to Day 99
Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）
时间窗: From baseline to Day 99
Chloride（CL）
时间窗: From baseline to Day 99
次要结局
- Vital signs(From baseline to Day 99)
- Clinical laboratory tests(From baseline to Day 99)
- Positive rate of neutralizing antibody (NAb)(From baseline to Day 99)
- Adverse Events(AEs)(From baseline to Day 99)
- Physical examinations(From baseline to Day 99)
- 12-lead ECGs(From baseline to Day 99)
- Positive rate of serum anti-drug antibody (ADA)(From baseline to Day 99)