Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers
- Registration Number
- NCT03317717
- Lead Sponsor
- Medy-Tox
- Brief Summary
This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 25
Inclusion Criteria
- 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
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description botulinum toxin 2U Meditoxin - botulinum toxin 2U Botox - botulinum toxin 5U Meditoxin - botulinum toxin 10U Meditoxin - botulinum toxin 20U Meditoxin - botulinum toxin 30U Meditoxin - botulinum toxin 10U Botox - botulinum toxin 5U Botox - botulinum toxin 20U Botox - botulinum toxin 30U Botox -
- Primary Outcome Measures
Name Time Method CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle day 14, 30, 60, 90 percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Catholic University of Korea, St. Paul's Hospital
🇰🇷Seoul, Korea, Republic of