Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

NCT ID: NCT03317717

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-12
• Study Completion Date: 2018-01-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

botulinum toxin 2U

Group Type: EXPERIMENTAL

Meditoxin

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Botox

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

botulinum toxin 5U

Group Type: EXPERIMENTAL

Meditoxin

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Botox

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

botulinum toxin 10U

Group Type: EXPERIMENTAL

Meditoxin

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Botox

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

botulinum toxin 20U

Group Type: EXPERIMENTAL

Meditoxin

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Botox

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

botulinum toxin 30U

Group Type: EXPERIMENTAL

Meditoxin

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Botox

Intervention Type: DRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Interventions

Meditoxin

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Intervention Type: DRUG

Botox

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Catholic University of Korea, St. Paul's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

MT01-KR17EDB107

Identifier Type: -

Identifier Source: org_study_id