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
1 other identifier
interventional
28
1 country
1
Brief Summary
To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Apr 2018
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2018
CompletedFirst Submitted
Initial submission to the registry
April 29, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedMarch 26, 2019
March 1, 2019
4 months
April 29, 2018
March 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
botulinum toxin 1U
EXPERIMENTALbotulinum toxin 5U
EXPERIMENTALbotulinum toxin 15U
EXPERIMENTALbotulinum toxin 30U
EXPERIMENTALInterventions
injection of MBA-P01 into the muscle of each contralateral foot in equal doses
injection of BOTOX into the muscle of each contralateral foot in equal doses
Eligibility Criteria
You may qualify if:
- Male adults aged between 20 and 45 years
You may not qualify if:
- Subjects not appropriate for participating in this study according to the investigator's opinion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medy-Toxlead
Study Sites (1)
The Catholic University of Korea, St. Paul's Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myungeun Chung
The Catholic University, St. Paul's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2018
First Posted
June 6, 2018
Study Start
April 16, 2018
Primary Completion
August 28, 2018
Study Completion
November 1, 2018
Last Updated
March 26, 2019
Record last verified: 2019-03