Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

To determine the pharmacodynamic and safety of MBA-P01 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 years

Exclusion criteria

Subjects not appropriate for participating in this study according to the investigator's opinion

Treatment and study plan

MBA-P01

Drug

injection of MBA-P01 into the muscle of each contralateral foot in equal doses

Botox

Drug

injection of BOTOX into the muscle of each contralateral foot in equal doses

Primary outcomes

to estimate the pharmacodynamic aspects of muscle

Time frame: day 3, 14, week 4, 8, 12

percentage of reduction of CMAP amplitude of the muscle from baseline

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled, Single-center, Phase 1 Study to Determine the Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jun 6, 2018
Registry last updated: Mar 26, 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