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Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547141
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Study Description
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Brief Summary:
To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: MBA-P01 Drug: BOTOX Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : April 16, 2018
Actual Primary Completion Date : August 28, 2018
Actual Study Completion Date : November 1, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547141


Locations
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Korea, Republic of
The Catholic University of Korea, St. Paul's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Medy-Tox
Investigators
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Principal Investigator: Myungeun Chung The Catholic University, St. Paul's Hospital
More Information
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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03547141    
Other Study ID Numbers: MT14-KR18EDB102
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No