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NCT03547141 Clinical Trial

Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03547141
Other study ID # MT14-KR18EDB102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 16, 2018
Est. completion date November 1, 2018

Study information
Verified date March 2019
Source Medy-Tox
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date November 1, 2018
Est. primary completion date August 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• MBA-P01
injection of MBA-P01 into the muscle of each contralateral foot in equal doses
• BOTOX
injection of BOTOX into the muscle of each contralateral foot in equal doses

Locations
Country Name City State
Korea, Republic of The Catholic University of Korea, St. Paul's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary to estimate the pharmacodynamic aspects of muscle percentage of reduction of CMAP amplitude of the muscle from baseline day 3, 14, week 4, 8, 12
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