NCT04175158Unknown1 期
A Randomized, Double-blind, Parallel-controlled Comparative Study to Evaluate the PK Pharmacokinetic Similarity After Single Administration of GB222 and Bevacizumab in Healthy Volunteers.
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- AUC 0- t
研究概览
简要总结
The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.
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
- Triple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
AUC 0- t
时间窗: Up to 84 days
AUC 0- t
次要结局
- Cmax(Up to 84 days)
- AUC0-∞(Up to 84 days)
- ADA(Up to 84 days)
研究者
研究点 (1)
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