Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

Medytox

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Botox; Drug: Meditoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03317717

MT01-KR17EDB107

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 5 patient groups

botulinum toxin 2U

Experimental group

Treatment:

Drug: Botox

Drug: Meditoxin

botulinum toxin 5U

Experimental group

Treatment:

Drug: Botox

Drug: Meditoxin

botulinum toxin 10U

Experimental group

Treatment:

Drug: Botox

Drug: Meditoxin

botulinum toxin 20U

Experimental group

Treatment:

Drug: Botox

Drug: Meditoxin

botulinum toxin 30U

Experimental group

Treatment:

Drug: Botox

Drug: Meditoxin