NL-OMON46410已完成不适用
An exploratory Phase I randomized, single-site, double-blind, active-controlled, parallel-group, single-administration, dose-escalation trial to investigate the safety and tolerability of neosaxitoxin alone and in combination with bupivacaine (with and without epinephrine), in perineural administrations for brachial plexus blockade in healthy subjects. - Trial to investigate safety and tolerability of neosaxitoxin
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
- •- Male subject, aged 18 years to 55 years, inclusive.;- Body mass index between 20.0 kg/m2 and 30.0 kg/m2 inclusive, with a minimal body weight of 60.0 kg.;- Subject must be in good health as determined by the prior/concomitant diseases, physical and laboratory examinations.;- Non-smoking or not more than 10 sigarettes, 2 cigars or 2 pipes per day
排除标准
- •Suffering from hepatitis B, hepatitis C, or HIV/AIDS. In case of participating in another drug study withing 1 month prior to the screening visit, donated 100 mL or more of blood between the screening visit and entry into the PRA research center excluding blood taken for this clinical study, donated 500 mL or more of blood within 3 months prior to the screening viist.
研究者
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