NCT03317717已完成1 期
Phase 1 Study to Determine the Pharmacodynamic and Safety of MEDITOXIN®(Clostridium Botulinum Toxin Type A) in Healthy Male Volunteers
Medy-Tox1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年10月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle
研究概览
简要总结
This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male adults aged between 20 and 45
- •Satisfying baseline nerve conduction criteria in below at screening visit CMAP M-wave amplitude of EDB ≥ 4.0mV CMAP M-wave amplitude of AH ≥ 5.0mV CMAP M-wave amplitude of ADQ ≥ 5.0mV
排除标准
- •Have history of childhood botulism
- •Have a pacemaker or any other heart device
- •Have peripheral neuropathy or accessary peroneal nerve
- •Have history of lower limb myotomy or denervation surgery
研究组 & 干预措施
botulinum toxin 2U
Experimental
干预措施: Meditoxin (Drug)
botulinum toxin 2U
Experimental
干预措施: Botox (Drug)
botulinum toxin 5U
Experimental
干预措施: Meditoxin (Drug)
botulinum toxin 5U
Experimental
干预措施: Botox (Drug)
botulinum toxin 10U
Experimental
干预措施: Meditoxin (Drug)
botulinum toxin 10U
Experimental
干预措施: Botox (Drug)
botulinum toxin 20U
Experimental
干预措施: Meditoxin (Drug)
botulinum toxin 20U
Experimental
干预措施: Botox (Drug)
botulinum toxin 30U
Experimental
干预措施: Meditoxin (Drug)
botulinum toxin 30U
Experimental
干预措施: Botox (Drug)
结局指标
主要结局
CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle
时间窗: day 14, 30, 60, 90
percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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