<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/NCT03800173</url>
  </required_header>
  <id_info>
    <org_study_id>BCX4430-106</org_study_id>
    <secondary_id>DMID18-0013</secondary_id>
    <secondary_id>272201300017C-18-0-1</secondary_id>
    <nct_id>NCT03800173</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430</brief_title>
  <official_title>A Phase 1 Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Galidesivir (BCX4430) Administered as Single Doses Via Intravenous Infusion in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioCryst Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>BioCryst Pharmaceuticals</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>
      This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics&#xD;
      of galidesivir following administration of single doses by IV infusion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single ascending dose study will evaluate the safety, tolerability, and PK of single&#xD;
      doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in&#xD;
      up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered&#xD;
      per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching&#xD;
      placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.</measure>
    <time_frame>AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1.</time_frame>
    <description>Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)</measure>
    <time_frame>Plasma PK parameters are based on sampling over a 21 day period</time_frame>
    <description>Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:&#xD;
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.&#xD;
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)&#xD;
Day 21 (+2 days) or early termination.&#xD;
Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)</measure>
    <time_frame>Plasma PK parameters are based on sampling over a 21 day period</time_frame>
    <description>Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:&#xD;
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.&#xD;
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)&#xD;
Day 21 (+2 days) or early termination.&#xD;
AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where &quot;t&quot; = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Galidesivir Renal Clearance</measure>
    <time_frame>Urine PK parameters are based on sampling over a 96 hour period.</time_frame>
    <description>Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Marburg Virus Disease</condition>
  <arm_group>
    <arm_group_label>Galidesivir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Galidesivir IV infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo IV infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>galidesivir</intervention_name>
    <description>galidesivir IV infusion</description>
    <arm_group_label>Galidesivir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo IV infusion</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  males and non-pregnant, non-lactating females&#xD;
&#xD;
          -  BMI 19.0-32.0&#xD;
&#xD;
          -  willing to abide by contraceptive requirements&#xD;
&#xD;
          -  normal vitals&#xD;
&#xD;
          -  willing to abide by study procedures and restrictions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinically significant medical condition or medical history or psychiatric condition&#xD;
             or history of psychiatric condition&#xD;
&#xD;
          -  abnormal cardiac finding, or laboratory/urinalysis abnormality at screening&#xD;
&#xD;
          -  known family history of sudden death or long QT syndrome, family or personal history&#xD;
             of QT prolongation, or arrhythmia that required medical intervention&#xD;
&#xD;
          -  current participation in any other investigational drug study or participation in an&#xD;
             investigational drug study within 3 months of screening visit&#xD;
&#xD;
          -  use of prescription, OTC, or herbal medications during study or use of any specified&#xD;
             medications within 30 days prior to study&#xD;
&#xD;
          -  Recent or current history of alcohol or drug abuse&#xD;
&#xD;
          -  Regular use of tobacco or nicotine products&#xD;
&#xD;
          -  Positive serology for HBV, HCV, or HIV&#xD;
&#xD;
          -  history of severe adverse reaction to or known sensitivity to any drug&#xD;
&#xD;
          -  pregnant, lactating, or planning to become pregnant within 30 days of the study. Male&#xD;
             subjects with pregnant female partners are excluded&#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>Daniel Dickerson, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PRA Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PRA Health Sciences</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>June 14, 2021</results_first_submitted>
  <results_first_submitted_qc>July 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2021</results_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</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>Virus Diseases</mesh_term>
    <mesh_term>Marburg Virus Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Galidesivir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03800173/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03800173/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A single dose of study drug was administered to subjects in each of cohorts 1 to 4. In each cohort, 6 subjects received galidesivir and 2 subjects received matching placebo.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>single placebo IV infusion</description>
        </group>
        <group group_id="P2">
          <title>5 mg/kg Galidesivir</title>
          <description>Single IV infusion 5 mg/kg galidesivir</description>
        </group>
        <group group_id="P3">
          <title>10 mg/kg Galidesivir</title>
          <description>Single IV infusion 10 mg/kg galidesivir</description>
        </group>
        <group group_id="P4">
          <title>15 mg/kg Galidesivir</title>
          <description>Single IV infusion 15 mg/kg galidesivir</description>
        </group>
        <group group_id="P5">
          <title>20 mg/kg Galidesivir</title>
          <description>Single IV infusion 20 mg/kg galidesivir</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PK Population</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety population included all randomized subjects who received any amount of study drug (i.e. a partial infusion). Subjects were analyzed according to the treatment received. The safety population was used for analyses of demographics.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>single placebo IV infusion</description>
        </group>
        <group group_id="B2">
          <title>5 mg/kg Galidesivir</title>
          <description>Single IV infusion 5 mg/kg galidesivir</description>
        </group>
        <group group_id="B3">
          <title>10 mg/kg Galidesivir</title>
          <description>Single IV infusion 10 mg/kg galidesivir</description>
        </group>
        <group group_id="B4">
          <title>15 mg/kg Galidesivir</title>
          <description>Single IV infusion 15 mg/kg galidesivir</description>
        </group>
        <group group_id="B5">
          <title>20 mg/kg Galidesivir</title>
          <description>Single IV infusion 20 mg/kg galidesivir</description>
        </group>
        <group group_id="B6">
          <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="8"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.1" spread="6.88"/>
                    <measurement group_id="B2" value="39.8" spread="10.76"/>
                    <measurement group_id="B3" value="33.5" spread="8.76"/>
                    <measurement group_id="B4" value="41.7" spread="12.04"/>
                    <measurement group_id="B5" value="31.8" spread="8.98"/>
                    <measurement group_id="B6" value="35.3" spread="9.87"/>
                  </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="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="19"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" 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 group_id="B5" value="0"/>
                    <measurement group_id="B6" 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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.</title>
        <description>Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).</description>
        <time_frame>AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1.</time_frame>
        <population>The safety population included all randomized subjects who received any amount of study drug (i.e. a partial infusion).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>single placebo IV infusion</description>
          </group>
          <group group_id="O2">
            <title>5 mg/kg Galidesivir</title>
            <description>Single IV infusion 5 mg/kg galidesivir</description>
          </group>
          <group group_id="O3">
            <title>10 mg/kg Galidesivir</title>
            <description>Single IV infusion 10 mg/kg galidesivir</description>
          </group>
          <group group_id="O4">
            <title>15 mg/kg Galidesivir</title>
            <description>Single IV infusion 15 mg/kg galidesivir</description>
          </group>
          <group group_id="O5">
            <title>20 mg/kg Galidesivir</title>
            <description>Single IV infusion 20 mg/kg galidesivir</description>
          </group>
        </group_list>
        <measure>
          <title>Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.</title>
          <description>Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).</description>
          <population>The safety population included all randomized subjects who received any amount of study drug (i.e. a partial infusion).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with at least 1 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with at least 1 SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject Discontinuation due to AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)</title>
        <description>Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:&#xD;
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.&#xD;
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)&#xD;
Day 21 (+2 days) or early termination.&#xD;
Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).</description>
        <time_frame>Plasma PK parameters are based on sampling over a 21 day period</time_frame>
        <population>The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>5 mg/kg Galidesivir</title>
            <description>Single IV infusion 5 mg/kg galidesivir</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg Galidesivir</title>
            <description>Single IV infusion 10 mg/kg galidesivir</description>
          </group>
          <group group_id="O3">
            <title>15 mg/kg Galidesivir</title>
            <description>Single IV infusion 15 mg/kg galidesivir</description>
          </group>
          <group group_id="O4">
            <title>20 mg/kg Galidesivir</title>
            <description>Single IV infusion 20 mg/kg galidesivir</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)</title>
          <description>Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:&#xD;
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.&#xD;
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)&#xD;
Day 21 (+2 days) or early termination.&#xD;
Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).</description>
          <population>The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5540" spread="7.8"/>
                    <measurement group_id="O2" value="10300" spread="22.3"/>
                    <measurement group_id="O3" value="17730" spread="17.5"/>
                    <measurement group_id="O4" value="20490" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A model with In-transformed dose (dose continuous) as a fixed effect &amp; subject as a random effect was applied to In-transformed Cmax. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model &amp; the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>0.982</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.868</ci_lower_limit>
            <ci_upper_limit>1.096</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)</title>
        <description>Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:&#xD;
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.&#xD;
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)&#xD;
Day 21 (+2 days) or early termination.&#xD;
AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where &quot;t&quot; = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).</description>
        <time_frame>Plasma PK parameters are based on sampling over a 21 day period</time_frame>
        <population>The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. Only 5 subjects were included in the 20 mg/kg cohort for AUC0-t analysis, as 1 subject was lost to follow-up after discharge from clinic on Day 5.</population>
        <group_list>
          <group group_id="O1">
            <title>5 mg/kg Galidesivir</title>
            <description>Single IV infusion 5 mg/kg galidesivir</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg Galidesivir</title>
            <description>Single IV infusion 10 mg/kg galidesivir</description>
          </group>
          <group group_id="O3">
            <title>15 mg/kg Galidesivir</title>
            <description>Single IV infusion 15 mg/kg galidesivir</description>
          </group>
          <group group_id="O4">
            <title>20 mg/kg Galidesivir</title>
            <description>Single IV infusion 20 mg/kg galidesivir</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)</title>
          <description>Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:&#xD;
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.&#xD;
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)&#xD;
Day 21 (+2 days) or early termination.&#xD;
AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where &quot;t&quot; = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).</description>
          <population>The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. Only 5 subjects were included in the 20 mg/kg cohort for AUC0-t analysis, as 1 subject was lost to follow-up after discharge from clinic on Day 5.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC0-inf</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21160" spread="23.0"/>
                    <measurement group_id="O2" value="37080" spread="14.5"/>
                    <measurement group_id="O3" value="65860" spread="21.9"/>
                    <measurement group_id="O4" value="81230" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-t</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17150" spread="21.0"/>
                    <measurement group_id="O2" value="32360" spread="17.4"/>
                    <measurement group_id="O3" value="59590" spread="22.0"/>
                    <measurement group_id="O4" value="73350" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A model with In-transformed dose (dose continuous) as a fixed effect &amp; subject as a random effect was applied to In-transformed AUC0-inf Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model &amp; the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>1.000</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.872</ci_lower_limit>
            <ci_upper_limit>1.128</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A model with In-transformed dose (dose continuous) as a fixed effect &amp; subject as a random effect was applied to In-transformed AUC0-t. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model &amp; the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>1.086</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.952</ci_lower_limit>
            <ci_upper_limit>1.219</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Galidesivir Renal Clearance</title>
        <description>Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes.</description>
        <time_frame>Urine PK parameters are based on sampling over a 96 hour period.</time_frame>
        <population>The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. There were only 5 subjects in the 20 mg/kg cohort as 1 subject was lost to follow-up after discharge from clinic on Day 5.</population>
        <group_list>
          <group group_id="O1">
            <title>5 mg/kg Galidesivir</title>
            <description>Single IV infusion 5 mg/kg galidesivir</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg Galidesivir</title>
            <description>Single IV infusion 10 mg/kg galidesivir</description>
          </group>
          <group group_id="O3">
            <title>15 mg/kg Galidesivir</title>
            <description>Single IV infusion 15 mg/kg galidesivir</description>
          </group>
          <group group_id="O4">
            <title>20 mg/kg Galidesivir</title>
            <description>Single IV infusion 20 mg/kg galidesivir</description>
          </group>
        </group_list>
        <measure>
          <title>Galidesivir Renal Clearance</title>
          <description>Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes.</description>
          <population>The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. There were only 5 subjects in the 20 mg/kg cohort as 1 subject was lost to follow-up after discharge from clinic on Day 5.</population>
          <units>L/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.305" spread="16.7"/>
                    <measurement group_id="O2" value="11.66" spread="17.8"/>
                    <measurement group_id="O3" value="11.51" spread="14.5"/>
                    <measurement group_id="O4" value="7.131" spread="90.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>single placebo IV infusion</description>
        </group>
        <group group_id="E2">
          <title>5 mg/kg Galidesivir</title>
          <description>Single IV infusion 5 mg/kg galidesivir</description>
        </group>
        <group group_id="E3">
          <title>10 mg/kg Galidesivir</title>
          <description>Single IV infusion 10 mg/kg galidesivir</description>
        </group>
        <group group_id="E4">
          <title>15 mg/kg Galidesivir</title>
          <description>Single IV infusion 15 mg/kg galidesivir</description>
        </group>
        <group group_id="E5">
          <title>20 mg/kg Galidesivir</title>
          <description>Single IV infusion 20 mg/kg galidesivir</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.1)</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>gastrooesophageal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (21.1)</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper airway cough syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>BioCryst Pharmaceuticals Inc</organization>
      <phone>+1 919-859-1302</phone>
      <email>clinicaltrials@biocryst.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/NCT03800173
org study id: BCX4430-106
secondary id: DMID18-0013
secondary id: 272201300017C-18-0-1
nct id: NCT03800173
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics
      of galidesivir following administration of single doses by IV infusion
This single ascending dose study will evaluate the safety, tolerability, and PK of single
      doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in
      up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered
      per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching
      placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
time frame: AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1.
description: Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).
measure: Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)
time frame: Plasma PK parameters are based on sampling over a 21 day period
description: Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.
Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).
measure: Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)
time frame: Plasma PK parameters are based on sampling over a 21 day period
description: Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.
AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).
measure: Galidesivir Renal Clearance
time frame: Urine PK parameters are based on sampling over a 96 hour period.
description: Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes.
arm group label: Galidesivir
arm group type: Experimental
description: Galidesivir IV infusion
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo IV infusion
intervention type: Drug
intervention name: galidesivir
description: galidesivir IV infusion
arm group label: Galidesivir
intervention type: Drug
intervention name: placebo
description: placebo IV infusion
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Dickerson, MD, PhD
role: Principal Investigator
affiliation: PRA Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Virus Diseases
mesh term: Marburg Virus Disease
mesh term: Galidesivir
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 