Status:
COMPLETED
Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers
Lead Sponsor:
Medy-Tox
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03317717
Start Date
October 12 2017
End Date
January 30 2018
Last Update
March 27 2019
Active Locations (1)
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1
The Catholic University of Korea, St. Paul's Hospital
Seoul, South Korea