<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/NCT04418297</url>
  </required_header>
  <id_info>
    <org_study_id>CT-G20 1.2</org_study_id>
    <nct_id>NCT04418297</nct_id>
  </id_info>
  <brief_title>A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celltrion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celltrion</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment,&#xD;
      ascending dose study in subjects with obstructive HCM aged 18-70 years. The purpose of this&#xD;
      study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The termination criteria of the protocol was met during dose escalation&#xD;
  </why_stopped>
  <start_date type="Actual">October 23, 2020</start_date>
  <completion_date type="Actual">November 22, 2022</completion_date>
  <primary_completion_date type="Actual">November 22, 2022</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product</measure>
    <time_frame>12 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Cardiomyopathy, Hypertrophic Obstructive</condition>
  <arm_group>
    <arm_group_label>CT-G20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CT-G20</intervention_name>
    <description>oral tablet</description>
    <arm_group_label>CT-G20</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral tablet</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men or women aged 18 to 70 years, inclusive at Screening&#xD;
&#xD;
          2. Has established diagnosis of HCM defined by standard criteria as a maximal left&#xD;
             ventricular wall thickness ≥15 mm at initial diagnosis in the absence of other&#xD;
             causative loading abnormalities capable of producing the magnitude of hypertrophy&#xD;
             observed or ≥13 mm if the subject has a family history of HCM&#xD;
&#xD;
          3. Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver,&#xD;
             due to SAM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known infiltrative, genetic or storage disorder causing cardiac hypertrophy that&#xD;
             mimics HCM, such as Fabry disease, amyloidosis or Noonan syndrome with LV hypertrophy&#xD;
&#xD;
          2. History of persistent atrial fibrillation prior to Screening or Baseline&#xD;
&#xD;
          3. History of paroxysmal atrial fibrillation requiring treatment (e.g., anti-coagulation&#xD;
             and/or antiarrhythmic therapy) within 3 months prior to Screening&#xD;
&#xD;
          4. Recently treated with invasive septal reduction (surgical myectomy or percutaneous&#xD;
             alcohol septal ablation) within 6 months prior to Screening or plans to have either of&#xD;
             these treatments during the study&#xD;
&#xD;
          5. Systolic heart failure with ejection fraction &lt;55% or heart failure symptoms of NYHA&#xD;
             Class IV&#xD;
&#xD;
          6. QTcF &gt;480 msec at Screening or Baseline&#xD;
&#xD;
          7. Presence of diseases classified as significant by the Investigator at Screening or&#xD;
             Baseline, including the following but not limited to:&#xD;
&#xD;
               1. Diabetes mellitus requiring treatment&#xD;
&#xD;
               2. Moderate or severe renal insufficiency or renal insufficiency with estimated&#xD;
                  glomerular filtration rate &lt;70 mL/min/1.73m2&#xD;
&#xD;
          8. Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives&#xD;
             (whichever is longer) prior to Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung-Ang University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06973</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Independent Public Central Clinical Hospital</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>02097</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Cardiology in Warsaw</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>04628</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</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>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertrophy</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/NCT04418297
org study id: CT-G20 1.2
nct id: NCT04418297
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment,
      ascending dose study in subjects with obstructive HCM aged 18-70 years. The purpose of this
      study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product
time frame: 12 days
arm group label: CT-G20
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: CT-G20
description: oral tablet
arm group label: CT-G20
intervention type: Drug
intervention name: Placebo
description: oral tablet
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy