NL-OMON42579已完成不适用
A single center, randomized, double-blind, 3-arm parallel Phase I study to assess pharmacokinetics, safety and tolerability of MYL-1402O solution for intravenous infusion after 90 minute intravenous infusion at one dose level (equivalent weight-adjusted dose (1 mg/kg) compared to the EU and US marketed drug product (Avastin®) in healthy male volunteers. - MYL-1402O equivalency study to EU and US marketed Avastin.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy male volunteers
- •18 - 55 years, inclusive
- •60 - 100 kilograms, inclusive
- •BMI 19.0 - 30.0 kilograms/meter2
- •Non smokers or Light smokers
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
研究者
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