<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/NCT03278470</url>
  </required_header>
  <id_info>
    <org_study_id>HL-237-101</org_study_id>
    <nct_id>NCT03278470</nct_id>
  </id_info>
  <brief_title>A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject</brief_title>
  <official_title>A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanlim Pharm. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanlim Pharm. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic&#xD;
      structure of biguanide in metformin, an existing diabetes drug.&#xD;
&#xD;
      The immune modulating activity of HL237 was demonstrated in animal model. HL237 is a STAT3&#xD;
      inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and&#xD;
      activating Treg cells.&#xD;
&#xD;
      Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune&#xD;
      diseases such as rheumatoid arthritis.&#xD;
&#xD;
      This is the first clinical trial to be conducted for the development of HL237 and this&#xD;
      clinical trial is for determining the maximum oral dose of HL237 and assessing safety,&#xD;
      tolerability, and pharmacokinetic characteristics for each dose group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Actual">March 19, 2018</completion_date>
  <primary_completion_date type="Actual">March 19, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration [Cmax]</measure>
    <time_frame>3days after administration</time_frame>
    <description>maximum serum concentration after the drug has been administrated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve [AUC]</measure>
    <time_frame>3days after administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>half life [t1/2]</measure>
    <time_frame>3days after administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events</measure>
    <time_frame>14days after administration</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>HL237 50mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>take oral tablet once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HL237 100mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>take oral tablet once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HL237 200mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>take oral tablet once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HL237 400mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>take oral tablet once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HL237 800mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>take oral tablet once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HL237 1200mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>take oral tablet once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HL237 1600mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>take oral tablet once</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HL237</intervention_name>
    <description>Experimental</description>
    <arm_group_label>HL237 100mg</arm_group_label>
    <arm_group_label>HL237 1200mg</arm_group_label>
    <arm_group_label>HL237 1600mg</arm_group_label>
    <arm_group_label>HL237 200mg</arm_group_label>
    <arm_group_label>HL237 400mg</arm_group_label>
    <arm_group_label>HL237 50mg</arm_group_label>
    <arm_group_label>HL237 800mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>placebo with same properties except for active ingredient</description>
    <arm_group_label>HL237 100mg</arm_group_label>
    <arm_group_label>HL237 1200mg</arm_group_label>
    <arm_group_label>HL237 1600mg</arm_group_label>
    <arm_group_label>HL237 200mg</arm_group_label>
    <arm_group_label>HL237 400mg</arm_group_label>
    <arm_group_label>HL237 50mg</arm_group_label>
    <arm_group_label>HL237 800mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A healthy adult male aged 20 years or older and 45 years old at the time of the&#xD;
             screening test&#xD;
&#xD;
          -  Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight&#xD;
&#xD;
          -  Proper contraception during the clinical trial period&#xD;
&#xD;
          -  After hearing the detailed explanation of the clinical trial, those who decide to&#xD;
             participate voluntarily and write agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant, a person with a history of neurological, psychiatric,&#xD;
             malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or&#xD;
             central disease&#xD;
&#xD;
          -  a person with a history of gastrointestinal disorders that may affect the absorption&#xD;
             of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or&#xD;
             gastrointestinal surgery (except for simple cecal surgery or hernia surgery)&#xD;
&#xD;
          -  a person with a history of hypersensitivity or clinically significant hypersensitivity&#xD;
             to the clinical trial drug or additives&#xD;
&#xD;
          -  a person judged to be inappropriate for the subject by health screening (history of&#xD;
             disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The catholic university of korea seoul ST. mary's hospital</name>
      <address>
        <city>Soeul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>August 16, 2018</last_update_submitted>
  <last_update_submitted_qc>August 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2018</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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT03278470
org study id: HL-237-101
nct id: NCT03278470
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic
      structure of biguanide in metformin, an existing diabetes drug.

      The immune modulating activity of HL237 was demonstrated in animal model. HL237 is a STAT3
      inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and
      activating Treg cells.

      Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune
      diseases such as rheumatoid arthritis.

      This is the first clinical trial to be conducted for the development of HL237 and this
      clinical trial is for determining the maximum oral dose of HL237 and assessing safety,
      tolerability, and pharmacokinetic characteristics for each dose group.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Maximum Plasma Concentration [Cmax]
time frame: 3days after administration
description: maximum serum concentration after the drug has been administrated
measure: Area Under the Curve [AUC]
time frame: 3days after administration
measure: half life [t1/2]
time frame: 3days after administration
measure: Number of participants with treatment-related adverse events
time frame: 14days after administration
arm group label: HL237 50mg
arm group type: Experimental
description: take oral tablet once
arm group label: HL237 100mg
arm group type: Experimental
description: take oral tablet once
arm group label: HL237 200mg
arm group type: Experimental
description: take oral tablet once
arm group label: HL237 400mg
arm group type: Experimental
description: take oral tablet once
arm group label: HL237 800mg
arm group type: Experimental
description: take oral tablet once
arm group label: HL237 1200mg
arm group type: Experimental
description: take oral tablet once
arm group label: HL237 1600mg
arm group type: Experimental
description: take oral tablet once
intervention type: Drug
intervention name: HL237
description: Experimental
arm group label: HL237 100mg
arm group label: HL237 1200mg
arm group label: HL237 1600mg
arm group label: HL237 200mg
arm group label: HL237 400mg
arm group label: HL237 50mg
arm group label: HL237 800mg
intervention type: Drug
intervention name: Placebo Oral Tablet
description: placebo with same properties except for active ingredient
arm group label: HL237 100mg
arm group label: HL237 1200mg
arm group label: HL237 1600mg
arm group label: HL237 200mg
arm group label: HL237 400mg
arm group label: HL237 50mg
arm group label: HL237 800mg
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid