Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MBA-P01; Drug: BOTOX

• Registration Number: NCT03547141
• Lead Sponsor: Medy-Tox

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-16
• Study First Submitted: 2018-04-29
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-06-06
• Primary Completion: 2018-08-28
• Study Completion: 2018-11-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin 1U	BOTOX	-
botulinum toxin 1U	MBA-P01	-
botulinum toxin 30U	MBA-P01	-
botulinum toxin 5U	MBA-P01	-
botulinum toxin 15U	MBA-P01	-
botulinum toxin 15U	BOTOX	-
botulinum toxin 5U	BOTOX	-
botulinum toxin 30U	BOTOX	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Catholic University of Korea, St. Paul's Hospital; 🇰🇷 Seoul, Korea, Republic of