<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03796351</url>
  </required_header>
  <id_info>
    <org_study_id>MT_PRT_EDB01</org_study_id>
    <nct_id>NCT03796351</nct_id>
  </id_info>
  <brief_title>Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®</brief_title>
  <official_title>A Randomized, Double-blind, Intra-Individual Controlled, Single-Center, Phase 1 Healthy Volunteer Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medy-Tox</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medy-Tox</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study design is a randomized, double-blind, intra-individual controlled, single-center,&#xD;
      phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are&#xD;
      judged to be eligible for this study will be intramuscularly injected with the study drug or&#xD;
      the comparator at a randomized unit(2U, 5U, 10U, 20U, 30U) in each site of the Extensor&#xD;
      digirotum brevis. Thereafter, follow-up visits will be made 14 days, 30days, 60days, 90days&#xD;
      and pharmacodynamic and safety assessments will be conducted for total 90days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised, double-blind, intra-individual controlled, dose escalation study to&#xD;
      assess the safety, tolerability and preliminary effectiveness of a single dose of MT10107 in&#xD;
      comparison to Botox®50U (BOTOX® is a registered trademark owned by Allergan). This is the&#xD;
      first-in-human study for MT10107, and will be performed in healthy volunteers.&#xD;
&#xD;
      Subjects will be administered a single equivalent dose of MT10107 and Botox®50U by&#xD;
      intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible&#xD;
      subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group&#xD;
      D (20 U dose) and Group E (30 U dose).&#xD;
&#xD;
      The foot in which each drug is to be administered (i.e. left or right) will be assigned in a&#xD;
      randomized manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.</measure>
    <time_frame>30 days after the injection</time_frame>
    <description>percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG.</measure>
    <time_frame>14, 30 and 90 days after the injection</time_frame>
    <description>percentage change of CMAP(Compound Muscle Action Potential) amplitude of the adjacent muscles (AH and ADQ) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.</measure>
    <time_frame>14 and 90 days after the injection</time_frame>
    <description>percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>MT10107(botulinum toxin type A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be administered a single equivalent dose of MT10107 by intramuscular injection to the EDB muscles of contralateral feet in five treatment group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BOTOX® 50U(botulinum toxin type A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT10107</intervention_name>
    <description>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).&#xD;
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.</description>
    <arm_group_label>MT10107(botulinum toxin type A)</arm_group_label>
    <other_name>Coretox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botox</intervention_name>
    <description>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).&#xD;
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.</description>
    <arm_group_label>BOTOX® 50U(botulinum toxin type A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male adults aged between 20 and 65 years&#xD;
&#xD;
          2. Subjects with CMAP M-wave amplitude of the EDM muscle of ≥ 4.0 mV, CMAP M-wave&#xD;
             amplitude of the AH muscle of ≥ 5.0 mV, and CMAP M-wave amplitude of the ADQ muscle of&#xD;
             ≥ 5.0 mV.&#xD;
&#xD;
          3. Have no clinically significant medical conditions.&#xD;
&#xD;
          4. Able to provide written informed consent.&#xD;
&#xD;
          5. Able to attend all assessment visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have previously been treated in 3 month with botulinum toxin type A.&#xD;
&#xD;
          2. Subjects who had childhood botulism.&#xD;
&#xD;
          3. Subjects who have a pacemaker or other heart device.&#xD;
&#xD;
          4. Subjects who have had previous myotomy or denervation surgery in the muscle of&#xD;
             interest (e.g., peripheral denervation and/or spinal cord stimulation).&#xD;
&#xD;
          5. Subjects with peripheral neuropathy and/or an accessary peroneal nerve.&#xD;
&#xD;
          6. Participation in any research study involving drug administration and/or significant&#xD;
             blood loss.&#xD;
&#xD;
          7. Subjects with laboratory (haematology and biochemistry) or urinalysis results out of&#xD;
             the normal range and considered to be of clinical significance by the investigator.&#xD;
&#xD;
          8. Subjects with a history of alcohol abuse and/or drug habituation.&#xD;
&#xD;
          9. Subjects who take regular medication.&#xD;
&#xD;
         10. Subjects with allergy or hypersensitivity to the investigational products or their&#xD;
             components&#xD;
&#xD;
         11. Subjects who have been given any of the following drugs within previous 4 weeks at&#xD;
             screening: Muscle relaxants, Benzodiazepines&#xD;
&#xD;
         12. Subjects who do not agree to use barrier method contraception (i.e. condoms) for the&#xD;
             duration of the study.&#xD;
&#xD;
         13. Subjects who participate in regular physical activity/sport, which requires high load&#xD;
             and intensity to the foot and cannot be stopped for the duration of the study.&#xD;
&#xD;
         14. Patients who are not eligible for this study at the discretion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MyungEun Chung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catholic University of Korea Saint Paul's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Paul's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 26, 2015</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03796351
org study id: MT_PRT_EDB01
nct id: NCT03796351
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.
time frame: 30 days after the injection
description: percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
measure: The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG.
time frame: 14, 30 and 90 days after the injection
description: percentage change of CMAP(Compound Muscle Action Potential) amplitude of the adjacent muscles (AH and ADQ) from baseline
measure: The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.
time frame: 14 and 90 days after the injection
description: percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
arm group label: MT10107(botulinum toxin type A)
arm group type: Experimental
description: Subjects will be administered a single equivalent dose of MT10107 by intramuscular injection to the EDB muscles of contralateral feet in five treatment group.
arm group label: BOTOX® 50U(botulinum toxin type A)
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: MT10107
description: 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.
arm group label: MT10107(botulinum toxin type A)
other name: Coretox
intervention type: Drug
intervention name: Botox
description: 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.
arm group label: BOTOX® 50U(botulinum toxin type A)
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: MyungEun Chung
role: Principal Investigator
affiliation: Catholic University of Korea Saint Paul's Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor