<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/NCT01670773</url>
  </required_header>
  <id_info>
    <org_study_id>CAT-1004-103</org_study_id>
    <nct_id>NCT01670773</nct_id>
  </id_info>
  <brief_title>A Study of CAT-1004 Biomarkers in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004</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 study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy&#xD;
      humans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation</measure>
    <time_frame>Pre/post each of 3 Single doses</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Other biomarkers including select cytokines and RNA gene expression may also be assessed</measure>
    <time_frame>Pre/post each of 3 Single doses</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Assessment of Mechanistic Blood Biomarkers in Healthy Humans</condition>
  <arm_group>
    <arm_group_label>CAT-1004 Dose #1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose #1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salsalate + DHA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose #2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single Dose #3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CAT-1004</intervention_name>
    <arm_group_label>CAT-1004 Dose #1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salsalate + DHA</intervention_name>
    <arm_group_label>Salsalate + DHA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Good health as determined by medical history, vital signs, EGC, physical exam and&#xD;
             clinical lab results&#xD;
&#xD;
          -  BMI between 18 and 30 kg/m2 inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Viral or bacterial infection within 21 days prior to randomization&#xD;
&#xD;
          -  Use of prescription drugs, nonprescription drugs, herbals and dietary supplements&#xD;
             within 7 days prior to randomization&#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>Joanne Donovan, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Catabasis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ProMedica</name>
      <address>
        <city>Brighton</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salicylsalicylic acid</mesh_term>
  </intervention_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/NCT01670773
org study id: CAT-1004-103
nct id: NCT01670773
lead sponsor: 
has dmc: No
This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy
      humans.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation
time frame: Pre/post each of 3 Single doses
measure: Other biomarkers including select cytokines and RNA gene expression may also be assessed
time frame: Pre/post each of 3 Single doses
arm group label: CAT-1004 Dose #1
arm group type: Experimental
description: Single dose #1
arm group label: Salsalate + DHA
arm group type: Active Comparator
description: Single dose #2
arm group label: Placebo
arm group type: Placebo Comparator
description: Single Dose #3
intervention type: Drug
intervention name: CAT-1004
arm group label: CAT-1004 Dose #1
intervention type: Drug
intervention name: Salsalate + DHA
arm group label: Salsalate + DHA
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joanne Donovan, MD, PhD
role: Study Director
affiliation: Catabasis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Salicylsalicylic acid