NL-OMON35929已完成不适用
A phase I, single-centre, randomised, single-blinded, placebo-controlled single ascending dose study, followed by an open-label extension, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of ALX 0651, administered intravenously to healthy male volunteers. - ALX 0651 SAD and open-label extension in healthy male
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ablynx NV
- 入组人数
- 76
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 volunteer
- •- Age between 18-55 years
- •- BMI between 19-29 kg/m2
- •- Only non-smokers
排除标准
- •Suffering from: hepatitis B or C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study or in case of donating more than 1.5 liter of blood in the 10 months prior the start of this study.
研究者
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