<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/NCT04430283</url>
  </required_header>
  <id_info>
    <org_study_id>FDY-5301-203</org_study_id>
    <nct_id>NCT04430283</nct_id>
  </id_info>
  <brief_title>Evaluation of FDY-5301 in Major Trauma Patients in ICU</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 for the Prevention and Treatment of ICU Acquired Weakness in Major Trauma Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faraday Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faraday Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of&#xD;
      FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit&#xD;
      acquired weakness (ICUAW)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the trial is to evaluate the efficacy, safety, and PK of FDY-5301 compared to&#xD;
      placebo in trauma ICU patients at risk of ICUAW.&#xD;
&#xD;
      Muscle wasting occurs rapidly after major trauma and is often associated with multi-organ&#xD;
      failure lasting from a few weeks to a long term disability. It is believed that FDY-5301 may&#xD;
      help prevent or treat muscle weakness and organ dysfunction in major trauma patients.&#xD;
&#xD;
      Approximately 252 subjects will be randomized (1:1:1) to receive up to 7 daily bolus IV doses&#xD;
      of FDY-5301 at 1 mg/kg or 2 mg/kg, or volume-matched placebo. To ensure equal representation&#xD;
      in each group, the randomization will be stratified by the presence or absence of any pelvic&#xD;
      or lower limb fractures.&#xD;
&#xD;
      All subjects who satisfy the eligibility criteria will be randomly allocated to one of three&#xD;
      treatment groups (FDY-5301 low dose, FDY-5301 high dose, or placebo).&#xD;
&#xD;
      All subjects will be followed for 6 months.&#xD;
&#xD;
      This study will be conducted globally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated because of difficulty identifying patients that met the inclusion&#xD;
    criteria, as well as logistical difficulties in opening clinical ICU study sites.&#xD;
  </why_stopped>
  <start_date type="Actual">September 20, 2021</start_date>
  <completion_date type="Actual">March 4, 2022</completion_date>
  <primary_completion_date type="Actual">March 4, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>All subjects who fulfill all study edibility criteria will be randomized to receive one of the 3 treatments.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Chelsea Critical Care Physical Assessment Tool</measure>
    <time_frame>Day 10 or hospital discharge, whichever occurs first.</time_frame>
    <description>Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Organ Dysfunction Total Time to Recovery</measure>
    <time_frame>Day 28 or hospital discharge, whichever occurs first.</time_frame>
    <description>Organ dysfunction total time to recovery (TTR) until Day 28</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical Research Council Sum Score</measure>
    <time_frame>Day 28, or hospital discharge, whichever occurs first</time_frame>
    <description>Medical Research Council Sum Score (MRC-SS) at Day 28, or hospital discharge, whichever occurs first. The Medical Research Council Sum Score measures global peripheral muscle strength which ranges from 0 (complete paralysis) to 60 (normal strength). A higher score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sequential Organ Failure Assessment Score</measure>
    <time_frame>ICU hospital stay until Day 28 or ICU discharge if earlier</time_frame>
    <description>The Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category, this is scored during the ICU stay. The full-length Sequential Organ Failure Assessment score ranges from 0 to 24. A higher score indicates a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival at Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>Confirmation of survival status will be obtained by speaking directly with subject, via medical records, or public health records.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>ICU Acquired Weakness</condition>
  <arm_group>
    <arm_group_label>FDY-5301 Low Dose (1 mg/kg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FDY-5301 High Dose (2 mg/kg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.&#xD;
Other Names:&#xD;
Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FDY-5301</intervention_name>
    <description>FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml.</description>
    <arm_group_label>FDY-5301 High Dose (2 mg/kg)</arm_group_label>
    <arm_group_label>FDY-5301 Low Dose (1 mg/kg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-75 years&#xD;
&#xD;
          2. Major trauma defined as:&#xD;
&#xD;
               1. thoracic and/or abdominal and/or pelvic injury&#xD;
&#xD;
               2. necessitating admission to ICU with ventilation anticipated for at least 24 hrs&#xD;
&#xD;
               3. hemorrhagic shock defined as systolic blood pressure (SBP) &lt;90 mmHG requiring&#xD;
                  blood transfusion or base deficit of at least 6mEq/L pre-hospital arrival or&#xD;
                  within one hour after hospital arrival&#xD;
&#xD;
          3. IRB/IEC-approved consent obtained within 48 hours of first hospital arrival time&#xD;
             (i.e., in case of transfers, use time of arrival to first hospital immediately post&#xD;
             injury)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Likely to die within 48 hrs from time of screening&#xD;
&#xD;
          2. Any neurological condition that is perceived at the time of hospital admission as an&#xD;
             immediate threat to life or incompatible with good functional recovery and where early&#xD;
             limitation or withdrawal of therapy is being considered. For example:&#xD;
&#xD;
             a. Computed tomography imaging showing evidence of traumatic brain injury (TBI),&#xD;
             combined with best representative Glasgow Coma Score (GCS) Motor Score of ≤4 at&#xD;
             approximately 24 hrs post injury&#xD;
&#xD;
          3. Evidence of nonreversible spinal cord injury&#xD;
&#xD;
          4. Bilateral femoral fractures&#xD;
&#xD;
          5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a&#xD;
             negative serum pregnancy test prior to randomization.&#xD;
&#xD;
          6. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone&#xD;
             replacement therapy at the time of randomization&#xD;
&#xD;
          7. Known allergy to iodine&#xD;
&#xD;
          8. Chronic renal disease requiring dialysis&#xD;
&#xD;
          9. Body mass index (BMI) &gt;40 kg/m2 or &lt;16 kg/m2&#xD;
&#xD;
         10. Body weight (BW) &gt;140 kg (or &gt;309 lb)&#xD;
&#xD;
         11. History or presence of debilitating neurologic or other neuromuscular disease (e.g.,&#xD;
             spina bifida, amyotrophic lateral sclerosis, multiple sclerosis) at time of&#xD;
             randomization&#xD;
&#xD;
         12. Current metastatic cancer&#xD;
&#xD;
         13. Solid organ transplant recipient&#xD;
&#xD;
         14. Evidence of pre-existing sarcopenia defined as having a pre-trauma Clinical Frailty&#xD;
             Score (CFS) of ≥5 or based on clinical judgement (e.g. frail by appearance, cachexia,&#xD;
             etc.)&#xD;
&#xD;
         15. Use of systemic corticosteroids, immunomodulators, or oncologic chemotherapy within 6&#xD;
             months of randomization (inhaled and topical steroids are allowed)&#xD;
&#xD;
         16. Use of investigational drugs or devices within 30 days of randomization&#xD;
&#xD;
         17. Any clinically significant abnormality identified prior to randomization that in the&#xD;
             judgment of the Investigator or Sponsor would preclude safe completion of the study,&#xD;
             or confound the anticipated benefit of FDY-5301&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital, Harvard Medical School</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>April 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <results_first_submitted>April 17, 2023</results_first_submitted>
  <results_first_submitted_qc>June 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 13, 2023</results_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ICU acquired weakness, PICS, SIRS</keyword>
  <keyword>Muscle wasting and weakness</keyword>
  <keyword>muscle function</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthenia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04430283/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>FDY-5301 Low Dose</title>
          <description>1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
        </group>
        <group group_id="P2">
          <title>FDY-5301 High Dose</title>
          <description>2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo will be administered intravenously once daily for up to 7 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FDY-5301 Low Dose</title>
          <description>1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
        </group>
        <group group_id="B2">
          <title>FDY-5301 High Dose</title>
          <description>2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo will be administered intravenously once daily for up to 7 days.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34" lower_limit="29" upper_limit="39"/>
                    <measurement group_id="B2" value="32.5" lower_limit="32" upper_limit="33"/>
                    <measurement group_id="B3" value="25.25" lower_limit="22" upper_limit="30"/>
                    <measurement group_id="B4" value="29.25" lower_limit="22" upper_limit="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Chelsea Critical Care Physical Assessment Tool</title>
        <description>Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.</description>
        <time_frame>Day 10 or hospital discharge, whichever occurs first.</time_frame>
        <population>Overall number of participants analyzed for CPAx data includes only those who have Day 10 CPAx scores. The small number of subjects enrolled in each of the groups preclude interpretation of the CPAx data.</population>
        <group_list>
          <group group_id="O1">
            <title>FDY-5301 Low Dose</title>
            <description>1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FDY-5301 High Dose</title>
            <description>2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo will be administered intravenously once daily for up to 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Chelsea Critical Care Physical Assessment Tool</title>
          <description>Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.</description>
          <population>Overall number of participants analyzed for CPAx data includes only those who have Day 10 CPAx scores. The small number of subjects enrolled in each of the groups preclude interpretation of the CPAx data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="9"/>
                    <measurement group_id="O2" value="31.5" lower_limit="28" upper_limit="35"/>
                    <measurement group_id="O3" value="11" lower_limit="10" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Organ Dysfunction Total Time to Recovery</title>
        <description>Organ dysfunction total time to recovery (TTR) until Day 28</description>
        <time_frame>Day 28 or hospital discharge, whichever occurs first.</time_frame>
        <population>The small number of subjects enrolled in each of the groups preclude interpretation of the organ dysfunction total TTR data.</population>
        <group_list>
          <group group_id="O1">
            <title>FDY-5301 Low Dose</title>
            <description>1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FDY-5301 High Dose</title>
            <description>2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo will be administered intravenously once daily for up to 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Organ Dysfunction Total Time to Recovery</title>
          <description>Organ dysfunction total time to recovery (TTR) until Day 28</description>
          <population>The small number of subjects enrolled in each of the groups preclude interpretation of the organ dysfunction total TTR data.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="5" upper_limit="12"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="O3" value="6" lower_limit="4" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medical Research Council Sum Score</title>
        <description>Medical Research Council Sum Score (MRC-SS) at Day 28, or hospital discharge, whichever occurs first. The Medical Research Council Sum Score measures global peripheral muscle strength which ranges from 0 (complete paralysis) to 60 (normal strength). A higher score indicates a better outcome.</description>
        <time_frame>Day 28, or hospital discharge, whichever occurs first</time_frame>
        <population>The small number of subjects enrolled in each of the groups preclude interpretation of the MRC-SS data.</population>
        <group_list>
          <group group_id="O1">
            <title>FDY-5301 Low Dose</title>
            <description>1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FDY-5301 High Dose</title>
            <description>2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo will be administered intravenously once daily for up to 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Medical Research Council Sum Score</title>
          <description>Medical Research Council Sum Score (MRC-SS) at Day 28, or hospital discharge, whichever occurs first. The Medical Research Council Sum Score measures global peripheral muscle strength which ranges from 0 (complete paralysis) to 60 (normal strength). A higher score indicates a better outcome.</description>
          <population>The small number of subjects enrolled in each of the groups preclude interpretation of the MRC-SS data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="20"/>
                    <measurement group_id="O3" value="31.5" lower_limit="15" upper_limit="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sequential Organ Failure Assessment Score</title>
        <description>The Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category, this is scored during the ICU stay. The full-length Sequential Organ Failure Assessment score ranges from 0 to 24. A higher score indicates a worse outcome.</description>
        <time_frame>ICU hospital stay until Day 28 or ICU discharge if earlier</time_frame>
        <population>The small number of subjects enrolled in each of the groups preclude interpretation of the SOFA data.</population>
        <group_list>
          <group group_id="O1">
            <title>FDY-5301 Low Dose</title>
            <description>1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FDY-5301 High Dose</title>
            <description>2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo will be administered intravenously once daily for up to 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Sequential Organ Failure Assessment Score</title>
          <description>The Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category, this is scored during the ICU stay. The full-length Sequential Organ Failure Assessment score ranges from 0 to 24. A higher score indicates a worse outcome.</description>
          <population>The small number of subjects enrolled in each of the groups preclude interpretation of the SOFA data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="6" upper_limit="9"/>
                    <measurement group_id="O2" value="6.5" lower_limit="6" upper_limit="7"/>
                    <measurement group_id="O3" value="7.5" lower_limit="4" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival at Day 28</title>
        <description>Confirmation of survival status will be obtained by speaking directly with subject, via medical records, or public health records.</description>
        <time_frame>Day 28</time_frame>
        <population>The small number of subjects enrolled in each of the groups preclude interpretation of the Overall Survival at Day 28 data.</population>
        <group_list>
          <group group_id="O1">
            <title>FDY-5301 Low Dose</title>
            <description>1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FDY-5301 High Dose</title>
            <description>2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo will be administered intravenously once daily for up to 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival at Day 28</title>
          <description>Confirmation of survival status will be obtained by speaking directly with subject, via medical records, or public health records.</description>
          <population>The small number of subjects enrolled in each of the groups preclude interpretation of the Overall Survival at Day 28 data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events occurring from the time of consent until Day 28 were collected.</time_frame>
      <desc>All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.</desc>
      <group_list>
        <group group_id="E1">
          <title>FDY-5301 Low Dose</title>
          <description>1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
        </group>
        <group group_id="E2">
          <title>FDY-5301 High Dose</title>
          <description>2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo will be administered intravenously once daily for up to 7 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram T wave abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hyporeflexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Faraday agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Faraday supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial through a multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Manager</name_or_title>
      <organization>Faraday Pharmaceuticals, Inc.</organization>
      <phone>206-492-5310</phone>
      <email>info@faradaypharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04430283
org study id: FDY-5301-203
nct id: NCT04430283
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of
      FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit
      acquired weakness (ICUAW)
The purpose of the trial is to evaluate the efficacy, safety, and PK of FDY-5301 compared to
      placebo in trauma ICU patients at risk of ICUAW.

      Muscle wasting occurs rapidly after major trauma and is often associated with multi-organ
      failure lasting from a few weeks to a long term disability. It is believed that FDY-5301 may
      help prevent or treat muscle weakness and organ dysfunction in major trauma patients.

      Approximately 252 subjects will be randomized (1:1:1) to receive up to 7 daily bolus IV doses
      of FDY-5301 at 1 mg/kg or 2 mg/kg, or volume-matched placebo. To ensure equal representation
      in each group, the randomization will be stratified by the presence or absence of any pelvic
      or lower limb fractures.

      All subjects who satisfy the eligibility criteria will be randomly allocated to one of three
      treatment groups (FDY-5301 low dose, FDY-5301 high dose, or placebo).

      All subjects will be followed for 6 months.

      This study will be conducted globally.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All subjects who fulfill all study edibility criteria will be randomized to receive one of the 3 treatments.
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
measure: Chelsea Critical Care Physical Assessment Tool
time frame: Day 10 or hospital discharge, whichever occurs first.
description: Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.
measure: Organ Dysfunction Total Time to Recovery
time frame: Day 28 or hospital discharge, whichever occurs first.
description: Organ dysfunction total time to recovery (TTR) until Day 28
measure: Medical Research Council Sum Score
time frame: Day 28, or hospital discharge, whichever occurs first
description: Medical Research Council Sum Score (MRC-SS) at Day 28, or hospital discharge, whichever occurs first. The Medical Research Council Sum Score measures global peripheral muscle strength which ranges from 0 (complete paralysis) to 60 (normal strength). A higher score indicates a better outcome.
measure: Sequential Organ Failure Assessment Score
time frame: ICU hospital stay until Day 28 or ICU discharge if earlier
description: The Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category, this is scored during the ICU stay. The full-length Sequential Organ Failure Assessment score ranges from 0 to 24. A higher score indicates a worse outcome.
measure: Overall Survival at Day 28
time frame: Day 28
description: Confirmation of survival status will be obtained by speaking directly with subject, via medical records, or public health records.
arm group label: FDY-5301 Low Dose (1 mg/kg)
arm group type: Experimental
description: FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.
arm group label: FDY-5301 High Dose (2 mg/kg)
arm group type: Experimental
description: FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.
Other Names:
Saline
intervention type: Drug
intervention name: FDY-5301
description: FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml.
arm group label: FDY-5301 High Dose (2 mg/kg)
arm group label: FDY-5301 Low Dose (1 mg/kg)
intervention type: Other
intervention name: Placebo
description: Placebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Asthenia
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