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Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

NCT ID: NCT03547141

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2018-11-01

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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botulinum toxin 1U

Group Type EXPERIMENTAL

MBA-P01

Intervention Type DRUG

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

BOTOX

Intervention Type DRUG

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

botulinum toxin 5U

Group Type EXPERIMENTAL

MBA-P01

Intervention Type DRUG

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

BOTOX

Intervention Type DRUG

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

botulinum toxin 15U

Group Type EXPERIMENTAL

MBA-P01

Intervention Type DRUG

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

BOTOX

Intervention Type DRUG

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

botulinum toxin 30U

Group Type EXPERIMENTAL

MBA-P01

Intervention Type DRUG

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

BOTOX

Intervention Type DRUG

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

Interventions

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MBA-P01

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

Intervention Type DRUG

BOTOX

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myungeun Chung

Role: PRINCIPAL_INVESTIGATOR

The Catholic University, St. Paul's Hospital

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MT14-KR18EDB102

Identifier Type: -

Identifier Source: org_study_id

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