Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

Study Overview
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Brief Summary
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This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.

Official Title
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Phase 1 Study to Determine the Pharmacodynamic and Safety of MEDITOXIN®(Clostridium Botulinum Toxin Type A) in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Meditoxin
* Drug: Botox


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin 2U<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>Drug: Botox<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>|
| Experimental: botulinum toxin 5U<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>Drug: Botox<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>|
| Experimental: botulinum toxin 10U<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>Drug: Botox<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>|
| Experimental: botulinum toxin 20U<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>Drug: Botox<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>|
| Experimental: botulinum toxin 30U<br> | Drug: Meditoxin<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>Drug: Botox<br>* injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle | percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline | day 14, 30, 60, 90 |