<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/NCT04495478</url>
  </required_header>
  <id_info>
    <org_study_id>17748</org_study_id>
    <secondary_id>I4T-MC-JVDT</secondary_id>
    <nct_id>NCT04495478</nct_id>
  </id_info>
  <brief_title>A Study of Ramucirumab (LY3009806) in Healthy Participants</brief_title>
  <official_title>A Single-Dose Study in Healthy Participants to Characterize Ramucirumab Pharmacokinetics and Investigate Injection Site Reactions Following an Intravenous Infusion or Subcutaneous Administration of Ramucirumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</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 study evaluates a new formulation of ramucirumab, a drug approved for several types of&#xD;
      cancer.&#xD;
&#xD;
      In this study of healthy participants, a small amount of ramucirumab will be given by&#xD;
      injection either into a vein or just under the skin. Study doctors will measure the amount of&#xD;
      ramucirumab in the bloodstream.&#xD;
&#xD;
      Side effects and tolerability will be documented. The study will last for about 16 weeks for&#xD;
      each participant, including screening and follow up. Screening is required within 28 days&#xD;
      prior to entering the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">May 9, 2021</completion_date>
  <primary_completion_date type="Actual">May 9, 2021</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</measure>
    <time_frame>Baseline through Day 90</time_frame>
    <description>An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug</measure>
    <time_frame>Day 1 Predose through Day 90</time_frame>
    <description>Number of participants showing ISRs when the drug was administered subcutaneously were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab</measure>
    <time_frame>1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose</time_frame>
    <description>PK: AUC[0-∞] of Ramucirumab.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: Maximum Concentration (Cmax) of Ramucirumab</measure>
    <time_frame>1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose</time_frame>
    <description>PK: Cmax of Ramucirumab</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Placebo - Intravenous (IV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of placebo administered IV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>350 mg Ramucirumab IV</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - Subcutaneous (SC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of placebo administered SC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>350 mg Ramucirumab SC (1x2 mL)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>350 mg Ramucirumab SC (2x2 mL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>350 mg Ramucirumab SC (2x1 mL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>700 mg Ramucirumab SC (2x2 mL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramucirumab - IV</intervention_name>
    <description>Administered IV.</description>
    <arm_group_label>350 mg Ramucirumab IV</arm_group_label>
    <other_name>LY3009806</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - IV</intervention_name>
    <description>Administered IV.</description>
    <arm_group_label>Placebo - Intravenous (IV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramucirumab - SC</intervention_name>
    <description>Administered SC.</description>
    <arm_group_label>350 mg Ramucirumab SC (1x2 mL)</arm_group_label>
    <arm_group_label>350 mg Ramucirumab SC (2x1 mL)</arm_group_label>
    <arm_group_label>350 mg Ramucirumab SC (2x2 mL)</arm_group_label>
    <arm_group_label>700 mg Ramucirumab SC (2x2 mL)</arm_group_label>
    <other_name>LY3009806</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - SC</intervention_name>
    <description>Administered SC.</description>
    <arm_group_label>Placebo - Subcutaneous (SC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control&#xD;
             measures until study completion)&#xD;
&#xD;
          -  Have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index&#xD;
             (BMI) of 18 to 32 kilogram per square meter (kg/m ²), inclusive&#xD;
&#xD;
          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine&#xD;
             laboratory test results that are acceptable for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently participating in or completed a clinical trial within the last 30 days&#xD;
             or any other type of medical research judged to be incompatible with this study&#xD;
&#xD;
          -  Have previously participated or withdrawn from this study&#xD;
&#xD;
          -  Have or used to have health problems or laboratory test results or ECG readings that,&#xD;
             in the opinion of the doctor, could make it unsafe to participate, or could interfere&#xD;
             with understanding the results of the study&#xD;
&#xD;
          -  Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Inc</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <results_first_submitted>May 6, 2022</results_first_submitted>
  <results_first_submitted_qc>May 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 14, 2023</results_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ramucirumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</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>October 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT04495478/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>November 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT04495478/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo IV</title>
          <description>Participants received single dose of placebo administered Intravenously (IV).</description>
        </group>
        <group group_id="P2">
          <title>350 mg Ramucirumab IV</title>
          <description>Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion.</description>
        </group>
        <group group_id="P3">
          <title>Placebo SC</title>
          <description>Participants received single dose of placebo administered subcutaneously (SC).</description>
        </group>
        <group group_id="P4">
          <title>350 mg Ramucirumab SC (1x2 mL)</title>
          <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.</description>
        </group>
        <group group_id="P5">
          <title>350 mg Ramucirumab SC (2x2 mL)</title>
          <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.</description>
        </group>
        <group group_id="P6">
          <title>350 mg Ramucirumab SC (2x1 mL)</title>
          <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.</description>
        </group>
        <group group_id="P7">
          <title>700 mg Ramucirumab SC (2x2 mL)</title>
          <description>Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo IV</title>
          <description>Participants received single dose of placebo administered IV.</description>
        </group>
        <group group_id="B2">
          <title>350 mg Ramucirumab IV</title>
          <description>Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.</description>
        </group>
        <group group_id="B3">
          <title>Placebo SC</title>
          <description>Participants received single dose of placebo administered SC.</description>
        </group>
        <group group_id="B4">
          <title>350 mg Ramucirumab SC (1x2 mL)</title>
          <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.</description>
        </group>
        <group group_id="B5">
          <title>350 mg Ramucirumab SC (2x2 mL)</title>
          <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.</description>
        </group>
        <group group_id="B6">
          <title>350 mg Ramucirumab SC (2x1 mL)</title>
          <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.</description>
        </group>
        <group group_id="B7">
          <title>700 mg Ramucirumab SC (2x2 mL)</title>
          <description>Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.</description>
        </group>
        <group group_id="B8">
          <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="3"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="7"/>
            <count group_id="B6" value="7"/>
            <count group_id="B7" value="7"/>
            <count group_id="B8" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34" lower_limit="28" upper_limit="53"/>
                    <measurement group_id="B2" value="35" lower_limit="20" upper_limit="54"/>
                    <measurement group_id="B3" value="37" lower_limit="21" upper_limit="58"/>
                    <measurement group_id="B4" value="51" lower_limit="24" upper_limit="59"/>
                    <measurement group_id="B5" value="46" lower_limit="26" upper_limit="56"/>
                    <measurement group_id="B6" value="39" lower_limit="21" upper_limit="60"/>
                    <measurement group_id="B7" value="41" lower_limit="22" upper_limit="53"/>
                    <measurement group_id="B8" value="40" lower_limit="20" upper_limit="60"/>
                  </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="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="27"/>
                  </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 group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                  </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 group_id="B7" value="0"/>
                    <measurement group_id="B8" 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 group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="35"/>
                  </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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" 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 group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</title>
        <description>An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description>
        <time_frame>Baseline through Day 90</time_frame>
        <population>All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo IV</title>
            <description>Participants received single dose of placebo administered IV.</description>
          </group>
          <group group_id="O2">
            <title>350 mg Ramucirumab IV</title>
            <description>Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.</description>
          </group>
          <group group_id="O3">
            <title>Placebo SC</title>
            <description>Participants received single dose of placebo administered SC.</description>
          </group>
          <group group_id="O4">
            <title>350 mg Ramucirumab SC (1x2 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.</description>
          </group>
          <group group_id="O5">
            <title>350 mg Ramucirumab SC (2x2 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.</description>
          </group>
          <group group_id="O6">
            <title>350 mg Ramucirumab SC (2x1 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.</description>
          </group>
          <group group_id="O7">
            <title>700 mg Ramucirumab SC (2x2 mL)</title>
            <description>Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</title>
          <description>An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description>
          <population>All participants who received at least one dose of study drug.</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="3"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug</title>
        <description>Number of participants showing ISRs when the drug was administered subcutaneously were reported.</description>
        <time_frame>Day 1 Predose through Day 90</time_frame>
        <population>All participants who received at least one dose of study drug subcutaneously.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo SC</title>
            <description>Participants received single dose of placebo administered SC.</description>
          </group>
          <group group_id="O2">
            <title>350 mg Ramucirumab SC (1x2 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.</description>
          </group>
          <group group_id="O3">
            <title>350 mg Ramucirumab SC (2x2 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.</description>
          </group>
          <group group_id="O4">
            <title>350 mg Ramucirumab SC (2x1 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.</description>
          </group>
          <group group_id="O5">
            <title>700 mg Ramucirumab SC (2x2 mL)</title>
            <description>Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug</title>
          <description>Number of participants showing ISRs when the drug was administered subcutaneously were reported.</description>
          <population>All participants who received at least one dose of study drug subcutaneously.</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="12"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab</title>
        <description>PK: AUC[0-∞] of Ramucirumab.</description>
        <time_frame>1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose</time_frame>
        <population>All participants who received at least one dose of ramucirumab and had sufficient evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>350 mg Ramucirumab IV</title>
            <description>Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.</description>
          </group>
          <group group_id="O2">
            <title>350 mg Ramucirumab SC (1x2 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.</description>
          </group>
          <group group_id="O3">
            <title>350 mg Ramucirumab SC (2x2 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.</description>
          </group>
          <group group_id="O4">
            <title>350 mg Ramucirumab SC (2x1 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.</description>
          </group>
          <group group_id="O5">
            <title>700 mg Ramucirumab SC (2x2 mL)</title>
            <description>Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab</title>
          <description>PK: AUC[0-∞] of Ramucirumab.</description>
          <population>All participants who received at least one dose of ramucirumab and had sufficient evaluable PK data.</population>
          <units>hour*microgram per milliliter (h*μg/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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18700" spread="19"/>
                    <measurement group_id="O2" value="5250" spread="48"/>
                    <measurement group_id="O3" value="5140" spread="76"/>
                    <measurement group_id="O4" value="6350" spread="57"/>
                    <measurement group_id="O5" value="14200" spread="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK: Maximum Concentration (Cmax) of Ramucirumab</title>
        <description>PK: Cmax of Ramucirumab</description>
        <time_frame>1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose</time_frame>
        <population>All participants who received at least one dose of ramucirumab and had sufficient evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>350 mg Ramucirumab IV</title>
            <description>Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.</description>
          </group>
          <group group_id="O2">
            <title>350 mg Ramucirumab SC (1x2 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.</description>
          </group>
          <group group_id="O3">
            <title>350 mg Ramucirumab SC (2x2 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.</description>
          </group>
          <group group_id="O4">
            <title>350 mg Ramucirumab SC (2x1 mL)</title>
            <description>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.</description>
          </group>
          <group group_id="O5">
            <title>700 mg Ramucirumab SC (2x2 mL)</title>
            <description>Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Maximum Concentration (Cmax) of Ramucirumab</title>
          <description>PK: Cmax of Ramucirumab</description>
          <population>All participants who received at least one dose of ramucirumab and had sufficient evaluable PK data.</population>
          <units>μg/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="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116" spread="11"/>
                    <measurement group_id="O2" value="24" spread="56"/>
                    <measurement group_id="O3" value="20.2" spread="63"/>
                    <measurement group_id="O4" value="21" spread="66"/>
                    <measurement group_id="O5" value="46.7" spread="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Day 90</time_frame>
      <desc>All participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo IV</title>
          <description>Participants received single dose of placebo administered IV.</description>
        </group>
        <group group_id="E2">
          <title>350 mg Ramucirumab IV</title>
          <description>Participants received single 350 mg Ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.</description>
        </group>
        <group group_id="E3">
          <title>Placebo SC</title>
          <description>Participants received single dose of placebo administered SC.</description>
        </group>
        <group group_id="E4">
          <title>350 mg Ramucirumab SC (1x2 mL)</title>
          <description>Participants received single 350 mg Ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.</description>
        </group>
        <group group_id="E5">
          <title>350 mg Ramucirumab SC (2x2 mL)</title>
          <description>Participants received single 350 mg Ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.</description>
        </group>
        <group group_id="E6">
          <title>350 mg Ramucirumab SC (2x1 mL)</title>
          <description>Participants received single 350 mg Ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.</description>
        </group>
        <group group_id="E7">
          <title>700 mg Ramucirumab SC (2x2 mL)</title>
          <description>Participants received single 700 mg Ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</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="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </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>Neither Lilly or Supplier shall publish, discuss, or release data emanating from a study without the other party's express written permission which shall not be unreasonably withheld. Nothing herein shall limit supplier's right to respond to legal inquiries.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>ClinicalTrials.gov@lilly.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/NCT04495478
org study id: 17748
secondary id: I4T-MC-JVDT
nct id: NCT04495478
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates a new formulation of ramucirumab, a drug approved for several types of
      cancer.

      In this study of healthy participants, a small amount of ramucirumab will be given by
      injection either into a vein or just under the skin. Study doctors will measure the amount of
      ramucirumab in the bloodstream.

      Side effects and tolerability will be documented. The study will last for about 16 weeks for
      each participant, including screening and follow up. Screening is required within 28 days
      prior to entering the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
time frame: Baseline through Day 90
description: An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
measure: Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug
time frame: Day 1 Predose through Day 90
description: Number of participants showing ISRs when the drug was administered subcutaneously were reported.
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab
time frame: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose
description: PK: AUC[0-∞] of Ramucirumab.
measure: PK: Maximum Concentration (Cmax) of Ramucirumab
time frame: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose
description: PK: Cmax of Ramucirumab
arm group label: Placebo - Intravenous (IV)
arm group type: Experimental
description: Participants received single dose of placebo administered IV.
arm group label: 350 mg Ramucirumab IV
arm group type: Placebo Comparator
description: Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion.
arm group label: Placebo - Subcutaneous (SC)
arm group type: Experimental
description: Participants received single dose of placebo administered SC.
arm group label: 350 mg Ramucirumab SC (1x2 mL)
arm group type: Placebo Comparator
description: Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
arm group label: 350 mg Ramucirumab SC (2x2 mL)
arm group type: Experimental
description: Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
arm group label: 350 mg Ramucirumab SC (2x1 mL)
arm group type: Experimental
description: Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
arm group label: 700 mg Ramucirumab SC (2x2 mL)
arm group type: Experimental
description: Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
intervention type: Drug
intervention name: Ramucirumab - IV
description: Administered IV.
arm group label: 350 mg Ramucirumab IV
other name: LY3009806
intervention type: Drug
intervention name: Placebo - IV
description: Administered IV.
arm group label: Placebo - Intravenous (IV)
intervention type: Drug
intervention name: Ramucirumab - SC
description: Administered SC.
arm group label: 350 mg Ramucirumab SC (1x2 mL)
arm group label: 350 mg Ramucirumab SC (2x1 mL)
arm group label: 350 mg Ramucirumab SC (2x2 mL)
arm group label: 700 mg Ramucirumab SC (2x2 mL)
other name: LY3009806
intervention type: Drug
intervention name: Placebo - SC
description: Administered SC.
arm group label: Placebo - Subcutaneous (SC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ramucirumab
mesh term: Antibodies, Monoclonal
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 