Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03547141

Enrollment

Registered

2018-06-06

Start date

2018-04-16

Completion date

2018-11-01

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGMBA-P01

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

DRUGBOTOX

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026