Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®

A Randomized, Double-blind, Intra-Individual Controlled, Single-Center, Phase 1 Healthy Volunteer Study

This study design is a randomized, double-blind, intra-individual controlled, single-center, phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a randomized unit(2U, 5U, 10U, 20U, 30U) in each site of the Extensor digirotum brevis. Thereafter, follow-up visits will be made 14 days, 30days, 60days, 90days and pharmacodynamic and safety assessments will be conducted for total 90days.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: MT10107; Drug: Botox

Detailed Description

This is a randomised, double-blind, intra-individual controlled, dose escalation study to assess the safety, tolerability and preliminary effectiveness of a single dose of MT10107 in comparison to Botox®50U (BOTOX® is a registered trademark owned by Allergan). This is the first-in-human study for MT10107, and will be performed in healthy volunteers.

Subjects will be administered a single equivalent dose of MT10107 and Botox®50U by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).

The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, St. Paul's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male adults aged between 20 and 65 years
2. Subjects with CMAP M-wave amplitude of the EDM muscle of ≥ 4.0 mV, CMAP M-wave amplitude of the AH muscle of ≥ 5.0 mV, and CMAP M-wave amplitude of the ADQ muscle of ≥ 5.0 mV.
3. Have no clinically significant medical conditions.
4. Able to provide written informed consent.
5. Able to attend all assessment visits.

Exclusion Criteria:

1. Subjects who have previously been treated in 3 month with botulinum toxin type A.
2. Subjects who had childhood botulism.
3. Subjects who have a pacemaker or other heart device.
4. Subjects who have had previous myotomy or denervation surgery in the muscle of interest (e.g., peripheral denervation and/or spinal cord stimulation).
5. Subjects with peripheral neuropathy and/or an accessary peroneal nerve.
6. Participation in any research study involving drug administration and/or significant blood loss.
7. Subjects with laboratory (haematology and biochemistry) or urinalysis results out of the normal range and considered to be of clinical significance by the investigator.
8. Subjects with a history of alcohol abuse and/or drug habituation.
9. Subjects who take regular medication.
10. Subjects with allergy or hypersensitivity to the investigational products or their components
11. Subjects who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, Benzodiazepines
12. Subjects who do not agree to use barrier method contraception (i.e. condoms) for the duration of the study.
13. Subjects who participate in regular physical activity/sport, which requires high load and intensity to the foot and cannot be stopped for the duration of the study.
14. Patients who are not eligible for this study at the discretion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MT10107(botulinum toxin type A); Subjects will be administered a single equivalent dose of MT10107 by intramuscular injection to the EDB muscles of contralateral feet in five treatment group.	Drug: MT10107; Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose). The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.; Other Names: Coretox
ACTIVE_COMPARATOR: BOTOX® 50U(botulinum toxin type A); Subjects will be administered a single equivalent dose of BOTOX® 50U by intramuscular injection to the EDB muscles of contralateral feet in five treatment group.	Drug: Botox; Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose). The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.	percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline	30 days after the injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG.	percentage change of CMAP(Compound Muscle Action Potential) amplitude of the adjacent muscles (AH and ADQ) from baseline	14, 30 and 90 days after the injection
The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.	percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline	14 and 90 days after the injection

Collaborators and Investigators

• Sponsor: Medy-Tox
• Investigators: Principal Investigator: MyungEun Chung, Catholic University of Korea Saint Paul's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: November 26, 2015
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (ACTUAL): January 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MT_PRT_EDB01