<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/NCT03004638</url>
  </required_header>
  <id_info>
    <org_study_id>D5780C00005</org_study_id>
    <nct_id>NCT03004638</nct_id>
  </id_info>
  <brief_title>Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease</brief_title>
  <official_title>A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</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>
      To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of&#xD;
      MEDI6012 in subjects with stable atherosclerosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety,&#xD;
      Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects&#xD;
      with Stable Atherosclerotic Cardiovascular Disease&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">November 2, 2017</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Clinical Laboratory Evaluations Reported as TEAEs</measure>
    <time_frame>From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)</time_frame>
    <description>An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Vital Signs Reported as TEAEs</measure>
    <time_frame>From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)</time_frame>
    <description>Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Electrocardiogram Reported as TEAEs</measure>
    <time_frame>From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)</time_frame>
    <description>Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol (HDL-C)</measure>
    <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
    <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol Ester (HDL-CE)</measure>
    <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
    <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Cholesterol Ester</measure>
    <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
    <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein A1</measure>
    <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
    <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein A1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Low-density Lipoprotein Cholesterol (LDL-C).</measure>
    <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
    <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of LDL-C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein B</measure>
    <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
    <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein B.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Concentration for MEDI6012 Mass</measure>
    <time_frame>Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.</time_frame>
    <description>The trough concentration level of MEDI6012 following each dose is reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Concentration for Total LCAT Activity</measure>
    <time_frame>Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.</time_frame>
    <description>Lecithin-cholesterol acyltransferase (LCAT) is a plasma enzyme secreted by the liver. Serum LCAT activity was estimated to provide an alternative measure to LCAT mass in establishing the relationship between pharmacokinetics and pharmacodynamics of MEDI6012. Change in LCAT activity from baseline (pre-dose of each dose) to post doses was reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of MEDI6012</measure>
    <time_frame>Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Cmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
    <description>The maximum observed serum concentration following the first and third dose of MEDI6012 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI6012</measure>
    <time_frame>Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Tmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
    <description>The time to reach the maximum observed serum concentration following the first and third dose of MEDI6012 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio (Rac) of MEDI6012</measure>
    <time_frame>Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; The Rac following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
    <description>The accumulation ratio (Rac) is defined as the ratio of accumulation of a study drug going from a single dose to steady state with repeated administration. Accumulation ratio was reported on the basis of maximum concentration (ARC max) and area under the concentration-time curve (ARAUC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Half-life (t1/2) of MEDI6012</measure>
    <time_frame>The t1/2 following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
    <description>The t1/2 is the time measured for the serum concentration to decrease by one half after the third dose of MEDI6012.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration Time Curve to Last Measurable Time Point (AUClast) of MEDI6012</measure>
    <time_frame>Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; AUClast following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
    <description>The area under the concentration time-curve to the last measured concentration after the third dose of MEDI6012 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Anti-Drug Antibodies for MEDI6012</measure>
    <time_frame>For Cohorts 1 to 3 and Placebo arm: Pre-dose on Days 1 and 15, and on Days 29, 43, and 71; For Cohort 4 and Placebo IV push arm: Pre-dose on Days 1 and 10, and on Days 24, 38, and 66.</time_frame>
    <description>Participants with positive serum antibodies to MEDI6012 were reported.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Atherosclerosis</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>MEDI6012 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6012 120 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6012 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6012 IV Push</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo IV Push</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI6012 40 mg</intervention_name>
    <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
    <arm_group_label>MEDI6012 40 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI6012 120 mg</intervention_name>
    <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
    <arm_group_label>MEDI6012 120 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI6012 300 mg</intervention_name>
    <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
    <arm_group_label>MEDI6012 300 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo IV Push</intervention_name>
    <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
    <arm_group_label>Placebo IV Push</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI6012 IV Push</intervention_name>
    <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
    <arm_group_label>MEDI6012 IV Push</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-childbearing potential&#xD;
&#xD;
          -  Diagnosis of stable atherosclerotic CVD&#xD;
&#xD;
          -  Currently receiving a stable dose of Statin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable cardiovascular condition within 3 months of screening&#xD;
&#xD;
          -  Elective arterial revascularization with in the past month&#xD;
&#xD;
          -  Any planned arterial revascularization&#xD;
&#xD;
          -  Body mass index &lt;18 or &gt;45&#xD;
&#xD;
          -  Clinically significant ECG that may interfere with the interpretation of serial ECG&#xD;
             and QT interval changes at screening&#xD;
&#xD;
          -  Chronic kidney disease defined by estimated glomerular filtration rate of less than 30&#xD;
             mL/mim/1.73m2&#xD;
&#xD;
          -  Triglycerides greater than 500 mg/dL, LDL-C greater than 160 mg/dL, or HDL-C greater&#xD;
             than 60 for males, or 65 for females&#xD;
&#xD;
          -  Clinically significant vital sign abnormalities&#xD;
&#xD;
          -  Genetic disorder of cholesterol metabolism&#xD;
&#xD;
          -  History of overt liver disease&#xD;
&#xD;
          -  Poorly controlled endocrine disorder (Diabetes or Thyroid disorder)&#xD;
&#xD;
          -  Current or recent use of systemic corticosteroids&#xD;
&#xD;
          -  Recent or ongoing infection or febrile illness&#xD;
&#xD;
          -  History of active malignancy within 5 years&#xD;
&#xD;
          -  History of alcohol or recreational substance abuse in the past 6 months&#xD;
&#xD;
          -  Concurrent enrollment in another clinical study of any investigational drug therapy or&#xD;
             use of any biologicals within 6 months prior to screening or within 5 half-lives of an&#xD;
             investigational agent or biologic, whichever is longer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=4211&amp;filename=D5780C00005-CSP-amendment-1_REDACTED_16Jul2017_PDF-A.pdf</url>
    <description>D5780C00005-CSP-amendment-1_REDACTED_16Jul2017_PDF-A</description>
  </link>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=4211&amp;filename=5780C00005%20MEDI6012%20Statistical%20Analysis%20Plan_21Jul2017_Version2_Redacted_PDF-A.pdf</url>
    <description>5780C00005 MEDI6012 Statistical Analysis Plan_21Jul2017_Version2_Redacted_PDF-A.pdf</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <results_first_submitted>October 31, 2018</results_first_submitted>
  <results_first_submitted_qc>October 31, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 30, 2018</results_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atherosclerosis</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>CAD</keyword>
  <keyword>Atherosclerotic Cardiovascular Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <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>July 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03004638/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>July 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03004638/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 4 sites in the USA between 23Jan2017 and 02Nov2017.</recruitment_details>
      <pre_assignment_details>A total of 91 participants were screened, of which 32 participants were randomized in a 6:2 ratio to receive MEDI6012 or placebo in 4 cohorts (8 participants in each cohort). For Cohort 4, randomization happened in a 7:1 ratio to receive MEDI6012 or placebo due to an interactive voice/web response system programming issue.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
        </group>
        <group group_id="P2">
          <title>MEDI6012 40 mg</title>
          <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="P3">
          <title>MEDI6012 120 mg</title>
          <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="P4">
          <title>MEDI6012 300 mg</title>
          <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="P5">
          <title>Placebo IV Push</title>
          <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
        </group>
        <group group_id="P6">
          <title>MEDI6012 IV Push</title>
          <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="7"/>
              </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="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>As-treated population included all participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1: MEDI6012 40 mg</title>
          <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 2: MEDI6012 120 mg</title>
          <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 3: MEDI6012 300 mg</title>
          <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="B5">
          <title>Placebo IV Push</title>
          <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
        </group>
        <group group_id="B6">
          <title>Cohort 4: MEDI6012 IV Push</title>
          <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
        </group>
        <group group_id="B7">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="1"/>
            <count group_id="B6" value="7"/>
            <count group_id="B7" 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="67.8" spread="4.8"/>
                    <measurement group_id="B2" value="66.7" spread="3.3"/>
                    <measurement group_id="B3" value="68.8" spread="2.8"/>
                    <measurement group_id="B4" value="66.2" spread="2.6"/>
                    <measurement group_id="B5" value="65.0" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="B6" value="71.4" spread="4.2"/>
                    <measurement group_id="B7" value="68.2" spread="3.9"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="23"/>
                  </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 group_id="B7" 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 group_id="B7" 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_list>
                </category>
                <category>
                  <title>Black or African American</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="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</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="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="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.</description>
        <time_frame>From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.</description>
          <population>As-treated population included 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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TESAEs</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="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Clinical Laboratory Evaluations Reported as TEAEs</title>
        <description>An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.</description>
        <time_frame>From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Clinical Laboratory Evaluations Reported as TEAEs</title>
          <description>An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.</description>
          <population>As-treated population included 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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" 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="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Vital Signs Reported as TEAEs</title>
        <description>Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.</description>
        <time_frame>From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Vital Signs Reported as TEAEs</title>
          <description>Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.</description>
          <population>As-treated population included 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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypotension</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="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Electrocardiogram Reported as TEAEs</title>
        <description>Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.</description>
        <time_frame>From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Electrocardiogram Reported as TEAEs</title>
          <description>Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.</description>
          <population>As-treated population included 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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" 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="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol (HDL-C)</title>
        <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.</description>
        <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol (HDL-C)</title>
          <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.</description>
          <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>mg*h/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.72" spread="467.59"/>
                    <measurement group_id="O2" value="1355.64" spread="576.94"/>
                    <measurement group_id="O3" value="2874.86" spread="1232.21"/>
                    <measurement group_id="O4" value="6465.05" spread="2074.77"/>
                    <measurement group_id="O5" value="266.68" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="1803.12" spread="1684.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol Ester (HDL-CE)</title>
        <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.</description>
        <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug.The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol Ester (HDL-CE)</title>
          <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.</description>
          <population>As-treated population included all participants who received at least one dose of study drug.The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>mg*h/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.75" spread="422.76"/>
                    <measurement group_id="O2" value="1161.47" spread="506.67"/>
                    <measurement group_id="O3" value="2580.51" spread="1076.11"/>
                    <measurement group_id="O4" value="5710.09" spread="1622.36"/>
                    <measurement group_id="O5" value="273.03" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="1597.12" spread="1531.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Cholesterol Ester</title>
        <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.</description>
        <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Cholesterol Ester</title>
          <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.</description>
          <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>mg*h/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="373.04" spread="1060.76"/>
                    <measurement group_id="O2" value="2267.37" spread="1126.43"/>
                    <measurement group_id="O3" value="4047.38" spread="1314.67"/>
                    <measurement group_id="O4" value="9004.31" spread="2086.47"/>
                    <measurement group_id="O5" value="371.75" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="2649.56" spread="3039.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein A1</title>
        <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein A1.</description>
        <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein A1</title>
          <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein A1.</description>
          <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>mg*h/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="821.33" spread="1465.70"/>
                    <measurement group_id="O2" value="2440.48" spread="1021.34"/>
                    <measurement group_id="O3" value="3740.59" spread="1508.93"/>
                    <measurement group_id="O4" value="5302.87" spread="1739.86"/>
                    <measurement group_id="O5" value="-20.42" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="2399.42" spread="2611.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Low-density Lipoprotein Cholesterol (LDL-C).</title>
        <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of LDL-C.</description>
        <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Low-density Lipoprotein Cholesterol (LDL-C).</title>
          <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of LDL-C.</description>
          <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>mg*h/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.96" spread="886.81"/>
                    <measurement group_id="O2" value="1125.45" spread="872.40"/>
                    <measurement group_id="O3" value="1043.39" spread="700.00"/>
                    <measurement group_id="O4" value="3056.76" spread="1765.33"/>
                    <measurement group_id="O5" value="-78.79" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="1364.12" spread="2375.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein B</title>
        <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein B.</description>
        <time_frame>Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.</time_frame>
        <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein B</title>
          <description>The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein B.</description>
          <population>As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>mg*h/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-82.95" spread="667.65"/>
                    <measurement group_id="O2" value="-40.06" spread="477.21"/>
                    <measurement group_id="O3" value="145.42" spread="283.62"/>
                    <measurement group_id="O4" value="-374.38" spread="588.54"/>
                    <measurement group_id="O5" value="-239.17" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="73.01" spread="864.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Concentration for MEDI6012 Mass</title>
        <description>The trough concentration level of MEDI6012 following each dose is reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).</description>
        <time_frame>Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.</time_frame>
        <population>Pharmacokinetic (PK) population included all participants in the as-treated population who had at least one detectable lecithin-cholesterol acyltransferase (LCAT) serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Concentration for MEDI6012 Mass</title>
          <description>The trough concentration level of MEDI6012 following each dose is reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).</description>
          <population>Pharmacokinetic (PK) population included all participants in the as-treated population who had at least one detectable lecithin-cholesterol acyltransferase (LCAT) serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.0000" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="16.2684" spread="4.5094"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</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 group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O2" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O3" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O4" value="3.8646" spread="2.0753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.0000" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="2.4407" spread="2.1437"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</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 group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O2" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O3" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O4" value="5.4320" spread="2.6999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.0000" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="0.3980" spread="0.8900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</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 group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O2" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O3" value="0.5478" spread="0.8613"/>
                    <measurement group_id="O4" value="7.1622" spread="2.7936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Concentration for Total LCAT Activity</title>
        <description>Lecithin-cholesterol acyltransferase (LCAT) is a plasma enzyme secreted by the liver. Serum LCAT activity was estimated to provide an alternative measure to LCAT mass in establishing the relationship between pharmacokinetics and pharmacodynamics of MEDI6012. Change in LCAT activity from baseline (pre-dose of each dose) to post doses was reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).</description>
        <time_frame>Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.</time_frame>
        <population>PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. LCAT activity at Day 3 and Day 17 were not collected for Cohort 4. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Concentration for Total LCAT Activity</title>
          <description>Lecithin-cholesterol acyltransferase (LCAT) is a plasma enzyme secreted by the liver. Serum LCAT activity was estimated to provide an alternative measure to LCAT mass in establishing the relationship between pharmacokinetics and pharmacodynamics of MEDI6012. Change in LCAT activity from baseline (pre-dose of each dose) to post doses was reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).</description>
          <population>PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. LCAT activity at Day 3 and Day 17 were not collected for Cohort 4. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2046" spread="0.3035"/>
                    <measurement group_id="O2" value="0.0282" spread="0.9432"/>
                    <measurement group_id="O3" value="0.6710" spread="0.8715"/>
                    <measurement group_id="O4" value="0.9720" spread="0.7029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.0000" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O6" value="0.5503" spread="0.5960"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</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 group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1467" spread="0.8494"/>
                    <measurement group_id="O2" value="0.1700" spread="0.7582"/>
                    <measurement group_id="O3" value="0.2418" spread="0.9939"/>
                    <measurement group_id="O4" value="1.1188" spread="0.7320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4983" spread="0.3355"/>
                    <measurement group_id="O2" value="-0.1617" spread="0.7031"/>
                    <measurement group_id="O3" value="0.0824" spread="1.0816"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax) of MEDI6012</title>
        <description>The maximum observed serum concentration following the first and third dose of MEDI6012 was reported.</description>
        <time_frame>Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Cmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
        <population>PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax) of MEDI6012</title>
          <description>The maximum observed serum concentration following the first and third dose of MEDI6012 was reported.</description>
          <population>PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="5"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.17" spread="3.27"/>
                    <measurement group_id="O2" value="27.5" spread="7.78"/>
                    <measurement group_id="O3" value="83.7" spread="27.7"/>
                    <measurement group_id="O4" value="75.1" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.63" spread="3.5"/>
                    <measurement group_id="O2" value="27.1" spread="5.37"/>
                    <measurement group_id="O3" value="94.7" spread="33.1"/>
                    <measurement group_id="O4" value="28.5" spread="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI6012</title>
        <description>The time to reach the maximum observed serum concentration following the first and third dose of MEDI6012 was reported.</description>
        <time_frame>Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Tmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
        <population>PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI6012</title>
          <description>The time to reach the maximum observed serum concentration following the first and third dose of MEDI6012 was reported.</description>
          <population>PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0417" spread="0.00"/>
                    <measurement group_id="O2" value="0.0417" spread="0.00"/>
                    <measurement group_id="O3" value="0.0417" spread="0.00"/>
                    <measurement group_id="O4" value="0.000696" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0417" spread="0.00"/>
                    <measurement group_id="O2" value="14.0417" spread="0.00"/>
                    <measurement group_id="O3" value="14.0417" spread="0.00"/>
                    <measurement group_id="O4" value="9.00070" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Ratio (Rac) of MEDI6012</title>
        <description>The accumulation ratio (Rac) is defined as the ratio of accumulation of a study drug going from a single dose to steady state with repeated administration. Accumulation ratio was reported on the basis of maximum concentration (ARC max) and area under the concentration-time curve (ARAUC).</description>
        <time_frame>Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; The Rac following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
        <population>PK population. The Rac was not calculated for Cohort 4 as the first dose regimen (300 mg loading dose follow by 2nd dose given 48 hours later, therefore NCA was not performed for Dose 1) are different from 3rd dose (100 mg). The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Ratio (Rac) of MEDI6012</title>
          <description>The accumulation ratio (Rac) is defined as the ratio of accumulation of a study drug going from a single dose to steady state with repeated administration. Accumulation ratio was reported on the basis of maximum concentration (ARC max) and area under the concentration-time curve (ARAUC).</description>
          <population>PK population. The Rac was not calculated for Cohort 4 as the first dose regimen (300 mg loading dose follow by 2nd dose given 48 hours later, therefore NCA was not performed for Dose 1) are different from 3rd dose (100 mg). The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ARCmax</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="5"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" spread="0.214"/>
                    <measurement group_id="O2" value="1.01" spread="0.112"/>
                    <measurement group_id="O3" value="1.02" spread="0.177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ARAUC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.897" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O2" value="1.16" spread="0.0982"/>
                    <measurement group_id="O3" value="1.21" spread="0.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Half-life (t1/2) of MEDI6012</title>
        <description>The t1/2 is the time measured for the serum concentration to decrease by one half after the third dose of MEDI6012.</description>
        <time_frame>The t1/2 following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
        <population>PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Half-life (t1/2) of MEDI6012</title>
          <description>The t1/2 is the time measured for the serum concentration to decrease by one half after the third dose of MEDI6012.</description>
          <population>PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="NA">Standard deviation was not applicable as only one participant was evaluable for this reporting group.</measurement>
                    <measurement group_id="O2" value="1.79" spread="0.374"/>
                    <measurement group_id="O3" value="2.52" spread="0.702"/>
                    <measurement group_id="O4" value="2.6" spread="0.942"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration Time Curve to Last Measurable Time Point (AUClast) of MEDI6012</title>
        <description>The area under the concentration time-curve to the last measured concentration after the third dose of MEDI6012 was reported.</description>
        <time_frame>Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; AUClast following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.</time_frame>
        <population>PK population. The AUClast was not reported following first dose in Cohort 4 since NCA was not performed due to dosing period was only 48 hrs. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Time Curve to Last Measurable Time Point (AUClast) of MEDI6012</title>
          <description>The area under the concentration time-curve to the last measured concentration after the third dose of MEDI6012 was reported.</description>
          <population>PK population. The AUClast was not reported following first dose in Cohort 4 since NCA was not performed due to dosing period was only 48 hrs. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.</population>
          <units>µg*day/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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>
              <title>Dose 1</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="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="10.1"/>
                    <measurement group_id="O2" value="35.2" spread="17.8"/>
                    <measurement group_id="O3" value="152" spread="50.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</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="5"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.98" spread="5.61"/>
                    <measurement group_id="O2" value="48.3" spread="23.6"/>
                    <measurement group_id="O3" value="205" spread="63.7"/>
                    <measurement group_id="O4" value="38.6" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Anti-Drug Antibodies for MEDI6012</title>
        <description>Participants with positive serum antibodies to MEDI6012 were reported.</description>
        <time_frame>For Cohorts 1 to 3 and Placebo arm: Pre-dose on Days 1 and 15, and on Days 29, 43, and 71; For Cohort 4 and Placebo IV push arm: Pre-dose on Days 1 and 10, and on Days 24, 38, and 66.</time_frame>
        <population>Immunogenicity population included all participants in the as-treated population who had at least one serum sample for immunogenicity testing</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: MEDI6012 40 mg</title>
            <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: MEDI6012 120 mg</title>
            <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: MEDI6012 300 mg</title>
            <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IV Push</title>
            <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4: MEDI6012 IV Push</title>
            <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-Drug Antibodies for MEDI6012</title>
          <description>Participants with positive serum antibodies to MEDI6012 were reported.</description>
          <population>Immunogenicity population included all participants in the as-treated population who had at least one serum sample for immunogenicity testing</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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA positive at baseline</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 group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline</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 group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline (Day 1) to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Description (Arm-group)</description>
        </group>
        <group group_id="E2">
          <title>MEDI6012 40 mg</title>
          <description>Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="E3">
          <title>MEDI6012 120 mg</title>
          <description>Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="E4">
          <title>MEDI6012 300 mg</title>
          <description>Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.</description>
        </group>
        <group group_id="E5">
          <title>Placebo IV Push</title>
          <description>Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.</description>
        </group>
        <group group_id="E6">
          <title>MEDI6012 IV Push</title>
          <description>Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</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="6"/>
                <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="1"/>
                <counts group_id="E6" 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="6"/>
                <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="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="3" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <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="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infusion site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infusion site induration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infusion site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" 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="1"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" 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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" 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="1"/>
                <counts group_id="E6" 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>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" 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="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" 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="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <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="1"/>
                <counts group_id="E6" 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>MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Richard George</name_or_title>
      <organization>MedImmune LLC</organization>
      <phone>+1-301-398-5681</phone>
      <email>information.center@astrazenea.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/NCT03004638
org study id: D5780C00005
nct id: NCT03004638
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of
      MEDI6012 in subjects with stable atherosclerosis.
A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety,
      Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects
      with Stable Atherosclerotic Cardiovascular Disease
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
time frame: From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)
description: An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.
measure: Number of Participants With Abnormal Clinical Laboratory Evaluations Reported as TEAEs
time frame: From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)
description: An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.
measure: Number of Participants With Abnormal Vital Signs Reported as TEAEs
time frame: From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)
description: Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.
measure: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs
time frame: From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)
description: Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.
measure: Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol (HDL-C)
time frame: Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
description: The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.
measure: Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol Ester (HDL-CE)
time frame: Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
description: The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.
measure: Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Cholesterol Ester
time frame: Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
description: The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.
measure: Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein A1
time frame: Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
description: The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein A1.
measure: Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Low-density Lipoprotein Cholesterol (LDL-C).
time frame: Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
description: The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of LDL-C.
measure: Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein B
time frame: Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
description: The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein B.
measure: Change From Baseline in Serum Concentration for MEDI6012 Mass
time frame: Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.
description: The trough concentration level of MEDI6012 following each dose is reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).
measure: Change From Baseline in Serum Concentration for Total LCAT Activity
time frame: Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.
description: Lecithin-cholesterol acyltransferase (LCAT) is a plasma enzyme secreted by the liver. Serum LCAT activity was estimated to provide an alternative measure to LCAT mass in establishing the relationship between pharmacokinetics and pharmacodynamics of MEDI6012. Change in LCAT activity from baseline (pre-dose of each dose) to post doses was reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).
measure: Maximum Observed Serum Concentration (Cmax) of MEDI6012
time frame: Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Cmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
description: The maximum observed serum concentration following the first and third dose of MEDI6012 was reported.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI6012
time frame: Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Tmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
description: The time to reach the maximum observed serum concentration following the first and third dose of MEDI6012 was reported.
measure: Accumulation Ratio (Rac) of MEDI6012
time frame: Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; The Rac following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
description: The accumulation ratio (Rac) is defined as the ratio of accumulation of a study drug going from a single dose to steady state with repeated administration. Accumulation ratio was reported on the basis of maximum concentration (ARC max) and area under the concentration-time curve (ARAUC).
measure: Terminal Half-life (t1/2) of MEDI6012
time frame: The t1/2 following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
description: The t1/2 is the time measured for the serum concentration to decrease by one half after the third dose of MEDI6012.
measure: Area Under the Concentration Time Curve to Last Measurable Time Point (AUClast) of MEDI6012
time frame: Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; AUClast following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
description: The area under the concentration time-curve to the last measured concentration after the third dose of MEDI6012 was reported.
measure: Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
time frame: For Cohorts 1 to 3 and Placebo arm: Pre-dose on Days 1 and 15, and on Days 29, 43, and 71; For Cohort 4 and Placebo IV push arm: Pre-dose on Days 1 and 10, and on Days 24, 38, and 66.
description: Participants with positive serum antibodies to MEDI6012 were reported.
arm group label: MEDI6012 40 mg
arm group type: Experimental
description: Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
arm group label: MEDI6012 120 mg
arm group type: Experimental
description: Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
arm group label: MEDI6012 300 mg
arm group type: Experimental
description: Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
arm group label: MEDI6012 IV Push
arm group type: Experimental
description: Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
arm group label: Placebo IV Push
arm group type: Placebo Comparator
description: Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
intervention type: Drug
intervention name: MEDI6012 40 mg
description: Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
arm group label: MEDI6012 40 mg
intervention type: Drug
intervention name: Placebo
description: Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
arm group label: Placebo
intervention type: Drug
intervention name: MEDI6012 120 mg
description: Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
arm group label: MEDI6012 120 mg
intervention type: Drug
intervention name: MEDI6012 300 mg
description: Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
arm group label: MEDI6012 300 mg
intervention type: Drug
intervention name: Placebo IV Push
description: Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
arm group label: Placebo IV Push
intervention type: Drug
intervention name: MEDI6012 IV Push
description: Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
arm group label: MEDI6012 IV Push
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4211&filename=D5780C00005-CSP-amendment-1_REDACTED_16Jul2017_PDF-A.pdf
description: D5780C00005-CSP-amendment-1_REDACTED_16Jul2017_PDF-A
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4211&filename=5780C00005%20MEDI6012%20Statistical%20Analysis%20Plan_21Jul2017_Version2_Redacted_PDF-A.pdf
description: 5780C00005 MEDI6012 Statistical Analysis Plan_21Jul2017_Version2_Redacted_PDF-A.pdf
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 