Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2018-01-30
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medy-Tox
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

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