ACTRN12611000077965已完成1 期
A Randomised, Double-Blind, Intra-Individual Controlled, Single-Center, Phase I Dose Escalation Healthy Volunteer Study to Determine the Safety and Tolerability of MT10109 (Clostridium Botulinum Toxin Type A) in Comparison to Botox(Registered Trademark)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Medytox, Inc
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- Male
入选标准
- •1.Subjects with compound muscle action potential (CMAP) M-wave amplitude of the extensor digitorum brevis muscle of = 4.0 mV, CMAP M-wave amplitude of the Abductor hallicis muscle of = 5.0 mV, and CMAP M-wave amplitude of the Abductor digiti quinti muscle of = 5.0 mV.
- •2.Subjects with a normal muscle power of the toes (score = 5) on the Medical Research Council (MRC) scale.
- •3.Have no clinically significant medical or neurological conditions.
- •5.Able to attend all assessment visits.
排除标准
- •1.Subjects who have previously been treated with botulinum toxin type A.
- •2.Subjects who had childhood botulism.
- •3.Subjects who have had previous myotomy or denervation surgery in the muscle of interest (e.g., peripheral denervation and/or spinal cord stimulation).
- •4.Subjects who have a pacemaker or other heart device.
- •5.Subjects with peripheral neuropathy and/or an accessary peroneal nerve.
研究者
相似试验
已完成
不适用
Phase I Healthy Volunteer Study to Determine the Pharmacodynamic and Safety of MT10107 (Botulinum Type A Neurotoxin) in Comparison to BOTOX®.KCT0000541Medytox25
Enrolling By Invitation
不适用
A Randomized Double-blind Intraindividual Controlled Trial Efficacy of Botulinum Toxin A for Scar Prevention After Breast Augmentatiohealthy humanbotulinum toxin A,botox,scar preventionTCTR20200117002Thammasat University24
进行中（未招募）
1 期
Investigation of the effective and safe use of the drug product in the treatment of actinic keratosis on extremities and trunk/neck.EUCTR2017-000486-72-DEBiofrontera Bioscience GmbH56
进行中（未招募）
1 期
A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patientsParkinson diseaseEUCTR2015-002631-17-ESInstitut de Recerca del Hospital de la Santa Creu i Sant Pau18
进行中（未招募）
1 期
A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions to Iron-Deficient Blood DonorsFemale first-time bloddonors with iron deficiencyMedDRA version: 18.1Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851EUCTR2012-001529-28-DKPharmacosmos A/S