<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/NCT01725594</url>
  </required_header>
  <id_info>
    <org_study_id>CAT-2003-101</org_study_id>
    <nct_id>NCT01725594</nct_id>
  </id_info>
  <brief_title>A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003</brief_title>
  <official_title>A Two-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catabasis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catabasis Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple&#xD;
      ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses&#xD;
      (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a&#xD;
      high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency and severity of adverse events</measure>
    <time_frame>Screening to End of study (up to 4 weeks following randomization)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf of CAT-2003</measure>
    <time_frame>Days 1, 7 and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of CAT-1004</measure>
    <time_frame>Days 1, 7 and14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline for hematology, chemistry, coagulation and urinalysis</measure>
    <time_frame>Baseline through End of study (up to 4 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline for Physical exams</measure>
    <time_frame>Baseline through end of study (up to 4 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline for ECGs</measure>
    <time_frame>Baseline through end of study (up to 4 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in vital signs</measure>
    <time_frame>Baseline through end of study (up to 4 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia</measure>
    <time_frame>Baseline to end of study (up to 4 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Cohort A1, Dose Level 1: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A2, Dose Level 2: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A3, Dose Level 3: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A4, Dose Level 4: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A5, Dose Level 5: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A2: Dose Level 2: CAT 2003 or placebo fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A3: Dose level 3:CAT 2003 or placebo fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B1: Dose level 6: CAT 2003 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple dose for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B2: Dose level 7: CAT 2003 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple dose for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B3: Dose level 8: CAT 2003 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple dose for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B4: Dose level 9: CAT 2003 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple dose for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CAT 2003</intervention_name>
    <arm_group_label>Cohort A1, Dose Level 1: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort A2, Dose Level 2: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort A2: Dose Level 2: CAT 2003 or placebo fed</arm_group_label>
    <arm_group_label>Cohort A3, Dose Level 3: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort A3: Dose level 3:CAT 2003 or placebo fed</arm_group_label>
    <arm_group_label>Cohort A4, Dose Level 4: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort A5, Dose Level 5: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort B1: Dose level 6: CAT 2003 or placebo</arm_group_label>
    <arm_group_label>Cohort B2: Dose level 7: CAT 2003 or placebo</arm_group_label>
    <arm_group_label>Cohort B3: Dose level 8: CAT 2003 or placebo</arm_group_label>
    <arm_group_label>Cohort B4: Dose level 9: CAT 2003 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Cohort A1, Dose Level 1: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort A2, Dose Level 2: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort A2: Dose Level 2: CAT 2003 or placebo fed</arm_group_label>
    <arm_group_label>Cohort A3, Dose Level 3: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort A3: Dose level 3:CAT 2003 or placebo fed</arm_group_label>
    <arm_group_label>Cohort A4, Dose Level 4: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort A5, Dose Level 5: CAT 2003 or placebo fasting</arm_group_label>
    <arm_group_label>Cohort B1: Dose level 6: CAT 2003 or placebo</arm_group_label>
    <arm_group_label>Cohort B2: Dose level 7: CAT 2003 or placebo</arm_group_label>
    <arm_group_label>Cohort B3: Dose level 8: CAT 2003 or placebo</arm_group_label>
    <arm_group_label>Cohort B4: Dose level 9: CAT 2003 or placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria:&#xD;
&#xD;
          -  Provision of written informed consent prior to any study-specific procedure;&#xD;
&#xD;
          -  Good health as determined by medical history, physical examination, vital signs, ECG,&#xD;
             and clinical laboratory measurements;&#xD;
&#xD;
          -  Satisfies one of the following:&#xD;
&#xD;
               1. Females not of childbearing potential: non-pregnant and non-lactating; surgically&#xD;
                  sterile or postmenopausal for 2 years or at least 1 year with a follicle&#xD;
                  stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR&#xD;
&#xD;
               2. Males: surgically sterile, abstinent, or subject or partner is utilizing an&#xD;
                  acceptable contraceptive method during and 3 months after the last study dose;&#xD;
&#xD;
        Major Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant disease that requires a physician's care and/or would interfere&#xD;
             with study evaluations&#xD;
&#xD;
          -  Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as&#xD;
             assessed by the investigator, such as QTcF &gt;450;&#xD;
&#xD;
          -  Use of any investigational drug or participation in any investigational study within&#xD;
             30 days prior to screening or 5 half-lives of the study agent, whichever is longer;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lukasz Biernat, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medpace, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medpace CPU</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>July 9, 2013</last_update_submitted>
  <last_update_submitted_qc>July 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2013</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>Dyslipidemias</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/NCT01725594
org study id: CAT-2003-101
nct id: NCT01725594
lead sponsor: 
has dmc: No
This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple
      ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses
      (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a
      high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Frequency and severity of adverse events
time frame: Screening to End of study (up to 4 weeks following randomization)
measure: AUCinf of CAT-2003
time frame: Days 1, 7 and 14
measure: Cmax of CAT-1004
time frame: Days 1, 7 and14
measure: Changes from baseline for hematology, chemistry, coagulation and urinalysis
time frame: Baseline through End of study (up to 4 weeks)
measure: Changes from baseline for Physical exams
time frame: Baseline through end of study (up to 4 weeks)
measure: Changes from baseline for ECGs
time frame: Baseline through end of study (up to 4 weeks)
measure: Changes from baseline in vital signs
time frame: Baseline through end of study (up to 4 weeks)
measure: Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia
time frame: Baseline to end of study (up to 4 weeks)
arm group label: Cohort A1, Dose Level 1: CAT 2003 or placebo fasting
arm group type: Experimental
description: Single dose
arm group label: Cohort A2, Dose Level 2: CAT 2003 or placebo fasting
arm group type: Experimental
description: Single dose
arm group label: Cohort A3, Dose Level 3: CAT 2003 or placebo fasting
arm group type: Experimental
description: Single dose
arm group label: Cohort A4, Dose Level 4: CAT 2003 or placebo fasting
arm group type: Experimental
description: Single dose
arm group label: Cohort A5, Dose Level 5: CAT 2003 or placebo fasting
arm group type: Experimental
description: Single dose
arm group label: Cohort A2: Dose Level 2: CAT 2003 or placebo fed
arm group type: Experimental
description: Single dose
arm group label: Cohort A3: Dose level 3:CAT 2003 or placebo fed
arm group type: Experimental
description: Single dose
arm group label: Cohort B1: Dose level 6: CAT 2003 or placebo
arm group type: Experimental
description: Multiple dose for 14 days
arm group label: Cohort B2: Dose level 7: CAT 2003 or placebo
arm group type: Experimental
description: Multiple dose for 14 days
arm group label: Cohort B3: Dose level 8: CAT 2003 or placebo
arm group type: Experimental
description: Multiple dose for 14 days
arm group label: Cohort B4: Dose level 9: CAT 2003 or placebo
arm group type: Experimental
description: Multiple dose for 14 days
intervention type: Drug
intervention name: CAT 2003
arm group label: Cohort A1, Dose Level 1: CAT 2003 or placebo fasting
arm group label: Cohort A2, Dose Level 2: CAT 2003 or placebo fasting
arm group label: Cohort A2: Dose Level 2: CAT 2003 or placebo fed
arm group label: Cohort A3, Dose Level 3: CAT 2003 or placebo fasting
arm group label: Cohort A3: Dose level 3:CAT 2003 or placebo fed
arm group label: Cohort A4, Dose Level 4: CAT 2003 or placebo fasting
arm group label: Cohort A5, Dose Level 5: CAT 2003 or placebo fasting
arm group label: Cohort B1: Dose level 6: CAT 2003 or placebo
arm group label: Cohort B2: Dose level 7: CAT 2003 or placebo
arm group label: Cohort B3: Dose level 8: CAT 2003 or placebo
arm group label: Cohort B4: Dose level 9: CAT 2003 or placebo
intervention type: Drug
intervention name: Placebo
arm group label: Cohort A1, Dose Level 1: CAT 2003 or placebo fasting
arm group label: Cohort A2, Dose Level 2: CAT 2003 or placebo fasting
arm group label: Cohort A2: Dose Level 2: CAT 2003 or placebo fed
arm group label: Cohort A3, Dose Level 3: CAT 2003 or placebo fasting
arm group label: Cohort A3: Dose level 3:CAT 2003 or placebo fed
arm group label: Cohort A4, Dose Level 4: CAT 2003 or placebo fasting
arm group label: Cohort A5, Dose Level 5: CAT 2003 or placebo fasting
arm group label: Cohort B1: Dose level 6: CAT 2003 or placebo
arm group label: Cohort B2: Dose level 7: CAT 2003 or placebo
arm group label: Cohort B3: Dose level 8: CAT 2003 or placebo
arm group label: Cohort B4: Dose level 9: CAT 2003 or placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lukasz Biernat, M.D
role: Principal Investigator
affiliation: Medpace, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dyslipidemias