Healthy
Conditions
Brief summary
This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.
Interventions
DRUGMeditoxin
injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses
DRUGBotox
injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed