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

NCT03796351 | Completed Phase 1

• 1 other identifier: MT_PRT_EDB01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG.

  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.

  14 and 90 days after the injection

Study Arms (2)

MT10107(botulinum toxin type A)

EXPERIMENTAL

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

BOTOX® 50U(botulinum toxin type A)

ACTIVE COMPARATOR

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

Interventions

MT10107 DRUG

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.

Also known as: Coretox

MT10107(botulinum toxin type A)

Botox DRUG

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.

BOTOX® 50U(botulinum toxin type A)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male adults aged between 20 and 65 years
• 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.
• Have no clinically significant medical conditions.
• Able to provide written informed consent.
• Able to attend all assessment visits.

You may not qualify if:

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

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Interventions

coretox; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• MyungEun Chung

  Catholic University of Korea Saint Paul's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: January 8, 2019
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

KR (1)