<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/NCT04415346</url>
  </required_header>
  <id_info>
    <org_study_id>HU-014_P1_ULS</org_study_id>
    <nct_id>NCT04415346</nct_id>
  </id_info>
  <brief_title>A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity</brief_title>
  <official_title>A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huons Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huons Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Investigational Product: LIZTOX inj 100unit(HU-014)&#xD;
&#xD;
        -  Title : A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in&#xD;
           the Treatment of Post Stroke Upper Limb Spasticity&#xD;
&#xD;
        -  Sites and investigators : Asan Medical Center(Seoul), Min-ho Chun, M.D, Ph.D&#xD;
&#xD;
        -  Objective : To evaluate the safety of LIZTOX inj in the treatment of Post Stroke Upper&#xD;
           Limb Spasticity&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 6, 2019</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor</measure>
    <time_frame>Week 4, 8, 12 from baseline visit(=Investigational product Injection)</time_frame>
    <description>The rate of change in muscle tension measured by MAS</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Post Stroke Upper Limb Spasticity</condition>
  <arm_group>
    <arm_group_label>HU-014 Inj(Phase 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HU-014 Inj</intervention_name>
    <description>Clostridium botulinum type A</description>
    <arm_group_label>HU-014 Inj(Phase 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A subject who is diagnosed with Stroke at least six weeks prior to Screening.&#xD;
&#xD;
          -  A subject who has Modified ashworth scale(MAS) score which Wrist Flexor is ≥ 2 and&#xD;
             Flexor or Finger Flexor is ≥ 1.&#xD;
&#xD;
          -  A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of the&#xD;
             categories of hand hygiene, clothing, upper extremity, or pain for evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A subject who has medical history following. (Allergy, Chemodenervation(within 6&#xD;
             months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspiration&#xD;
             pneumonia, etc.)&#xD;
&#xD;
          -  A subject who has history of any diseases following. (neuromuscular junction disorder,&#xD;
             NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateral&#xD;
             sclerosis, ALS, Skin disease, Dysphagia, etc.)&#xD;
&#xD;
          -  From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis&#xD;
             implantation within 6 Weeks&#xD;
&#xD;
          -  Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside,&#xD;
             lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.&#xD;
&#xD;
          -  A subject who tend to bleed or are taking anti-coagulant drugs.&#xD;
&#xD;
          -  A sugject who is undergoing rehabilitation(physical therapy, occupational therapy,&#xD;
             exercise therapy) or Splinting in the area where medication for clinical trials is&#xD;
             scheduled to be administered.&#xD;
&#xD;
          -  A sugject who has muscle atrophy, fixed joint/muscle contracture in the area where&#xD;
             medication for clinical trials is scheduled to be administered.&#xD;
&#xD;
          -  Any condition that, in the view of the investigator, would interfere with study&#xD;
             participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min-ho Chun, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Medicine&amp;Rehabilitation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-gu</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 31, 2020</last_update_submitted>
  <last_update_submitted_qc>May 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT04415346
org study id: HU-014_P1_ULS
nct id: NCT04415346
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
-  Investigational Product: LIZTOX inj 100unit(HU-014)

        -  Title : A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in
           the Treatment of Post Stroke Upper Limb Spasticity

        -  Sites and investigators : Asan Medical Center(Seoul), Min-ho Chun, M.D, Ph.D

        -  Objective : To evaluate the safety of LIZTOX inj in the treatment of Post Stroke Upper
           Limb Spasticity
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor
time frame: Week 4, 8, 12 from baseline visit(=Investigational product Injection)
description: The rate of change in muscle tension measured by MAS
arm group label: HU-014 Inj(Phase 1
arm group type: Experimental
description: HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)
intervention type: Biological
intervention name: HU-014 Inj
description: Clostridium botulinum type A
arm group label: HU-014 Inj(Phase 1
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Min-ho Chun, M.D.,Ph.D.
role: Principal Investigator
affiliation: Department of Physical Medicine&Rehabilitation
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Stroke