An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline
研究概览
简要总结
To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian healthy adult male subjects by comparing electrophysiological reactions after administering E2014 to extensor digitorum brevis muscle (EDB).
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
- Single
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Participants who have a complication or history of peripheral neuropathy, nerve root impairment, muscle disease.
- •Participants with a disease that may influence the study drug evaluation, such as disorders of the gastrointestinal tract, liver, respiratory, endocrine, hematological, neurological, psychiatric and cardiovascular system, and congenital abnormality in metabolism.
- •Participants who have accessory deep peroneal nerve.
- •Participants who previously received a treatment with botulinum toxin.
- •Participants with a history of hypersensitivity to any component of E2014 (human serum albumin, succinate buffer solution).
- •Participants who are positive for urine drug screening at the time of screening or immediately before study drug administration.
- •Participants who received prescription drug(s) within 1 month before study drug administration.
- •Participants who have been treated with another investigational drug within 4 months before study drug administration.
- •Participants who have experienced heavy exercise or hard labor within 2 weeks before study drug administration.
- •Participants who underwent blood transfusion within 3 months before, those whose 400 mL of whole blood was collected within 3 months before, or those whose 200 mL of whole blood was collected within 1 month before study drug administration.
- •Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or serologic test for syphilis (STS).
- •Participants who received a diagnosis of acquired immunodeficiency syndrome (AIDS) or those with positive result for human immunodeficiency virus.
- •Participants who are unwilling or unable to abide by the requirements of this study, or those who may violate the prohibitions and restrictions of this study.
- •Participants who are judge to be ineligible for study entry by a principal investigator or subinvestigator.
研究组 & 干预措施
E2014 (Botulinum toxin type B)
干预措施: E2014 (Botulinum toxin type B) (Drug)
E2014 (Botulinum toxin type B) Placebo
干预措施: E2014 (Botulinum toxin type B) Placebo (Drug)
结局指标
主要结局
Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline
时间窗: Baseline and Up to Week 12
The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave amplitude reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave amplitude reduction from baseline were presented as a percentage.
Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline
时间窗: Baseline
The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline).
Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline
时间窗: Baseline and Up to 12 Weeks
The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave area reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave area reduction from baseline were presented as a percentage.
Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline
时间窗: Baseline
The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline).
次要结局
未报告次要终点