Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

March 25, 2019 updated by: Medy-Tox

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

To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, ST. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: botulinum toxin 1U
Drug: MBA-P01
injection of MBA-P01 into the muscle of each contralateral foot in equal doses
Drug: BOTOX
injection of BOTOX into the muscle of each contralateral foot in equal doses
EXPERIMENTAL: botulinum toxin 5U
Drug: MBA-P01
injection of MBA-P01 into the muscle of each contralateral foot in equal doses
Drug: BOTOX
injection of BOTOX into the muscle of each contralateral foot in equal doses
EXPERIMENTAL: botulinum toxin 15U
Drug: MBA-P01
injection of MBA-P01 into the muscle of each contralateral foot in equal doses
Drug: BOTOX
injection of BOTOX into the muscle of each contralateral foot in equal doses
EXPERIMENTAL: botulinum toxin 30U
Drug: MBA-P01
injection of MBA-P01 into the muscle of each contralateral foot in equal doses
Drug: BOTOX
injection of BOTOX into the muscle of each contralateral foot in equal doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 3, 14, week 4, 8, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medy-Tox

Investigators

  • Principal Investigator: Myungeun Chung, The Catholic University, St. Paul's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 16, 2018

Primary Completion (ACTUAL)

August 28, 2018

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

April 29, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (ACTUAL)

June 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • MT14-KR18EDB102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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