Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

Phase 1CompletedNCT03547141

Medy-Tox28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

MBA-P01DRUG

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

BOTOXDRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Seoul, South Korea

Outcomes

Primary Outcomes

to estimate the pharmacodynamic aspects of muscle

percentage of reduction of CMAP amplitude of the muscle from baseline

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

Data from ClinicalTrials.gov

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