Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditoxin

Drug

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

Botox

Drug

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

Primary outcomes

CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle

Time frame: day 14, 30, 60, 90

percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 23, 2017
Registry last updated: Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed