Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

Sponsor

Medy-Tox (Industry)

Overall Status

Completed

CT.gov ID

NCT03317717

Collaborator

(none)

Enrollment

Location

Arms

3.6

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Meditoxin Drug: Botox	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 12, 2017

Actual Primary Completion Date :

Jan 30, 2018

Actual Study Completion Date :

Jan 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle [day 14, 30, 60, 90]
percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea, St. Paul's Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Medy-Tox

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medy-Tox

ClinicalTrials.gov Identifier:

NCT03317717

Other Study ID Numbers:

MT01-KR17EDB107

First Posted:

Oct 23, 2017

Last Update Posted:

Mar 27, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Botulinum Toxins, Type A

Study Results

No Results Posted as of Mar 27, 2019