<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/NCT02255760</url>
  </required_header>
  <id_info>
    <org_study_id>D5470C00002</org_study_id>
    <nct_id>NCT02255760</nct_id>
  </id_info>
  <brief_title>Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults</brief_title>
  <official_title>A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of MEDI3902 in Healthy Adults</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>
      This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study&#xD;
      evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy&#xD;
      adult subjects 18 to 60 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study&#xD;
      evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy&#xD;
      adult subjects 18 to 60 years of age. Approximately 40 subjects will be enrolled across 4&#xD;
      fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting&#xD;
      a screening period of up to 28 days, 1 day of investigational product administration, and a&#xD;
      60 day safety follow up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2014</start_date>
  <completion_date type="Actual">April 20, 2015</completion_date>
  <primary_completion_date type="Actual">April 20, 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</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)</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)</measure>
    <time_frame>Day 1 to Day 61</time_frame>
    <description>An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event 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 that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Day 1 to Day 7</time_frame>
    <description>Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])</measure>
    <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
    <description>Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose</measure>
    <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
    <description>The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Phase Elimination Half-life (t1/2)</measure>
    <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
    <description>The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution at Steady State (Vss)</measure>
    <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MEDI3902 Serum Clearance (CL) of MEDI3902</measure>
    <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902</measure>
    <time_frame>Days 1 (pre-dose), 15, 29, and 61</time_frame>
    <description>Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>MEDI3902 for Prevention of P. Aeruginosa Pneumonia</condition>
  <arm_group>
    <arm_group_label>MEDI3902 - Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI3902 - Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI3902 - Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI3902 - Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI3902 - Dose 1</intervention_name>
    <description>Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
    <arm_group_label>MEDI3902 - Dose 1</arm_group_label>
    <other_name>MEDI3902</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI3902 - Dose 2</intervention_name>
    <description>Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
    <arm_group_label>MEDI3902 - Dose 2</arm_group_label>
    <other_name>MEDI3902</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI3902 - Dose 3</intervention_name>
    <description>Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
    <arm_group_label>MEDI3902 - Dose 3</arm_group_label>
    <other_name>MEDI3902</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI3902 - Dose 4</intervention_name>
    <description>Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
    <arm_group_label>MEDI3902 - Dose 4</arm_group_label>
    <other_name>MEDI3902</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 through 60 years at the time of screening&#xD;
&#xD;
          2. Written informed consent&#xD;
&#xD;
          3. Weight greater than or equal to (&gt;=) 45 kilogram (kg) and less than or equal to (&lt;=)&#xD;
             110 kg at screening&#xD;
&#xD;
          4. Healthy by medical history, physical examination, and baseline safety laboratory&#xD;
             studies&#xD;
&#xD;
          5. Systolic blood pressure (BP) less than (&lt;) 140 millimeter of mercury (mmHg) and&#xD;
             diastolic BP &lt; 90 mmHg at screening&#xD;
&#xD;
          6. Electrocardiogram (ECG) without clinically significant abnormalities at screening&#xD;
&#xD;
          7. Able to complete the follow-up period through Day 61 as required by the protocol.&#xD;
&#xD;
          8. Females of childbearing potential who are sexually active with a nonsterilized male&#xD;
             partner must have used a highly effective method of contraception for at least 28 days&#xD;
             prior to dosing with investigational product and must agree to continue using such&#xD;
             precautions through Day 61 of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute (time-limited) illness, including fever 99.5 degree Fahrenheit (0^F), on day&#xD;
             prior to or day of planned dosing&#xD;
&#xD;
          2. Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use&#xD;
             of acetaminophen, aspirin, antihistamine, or combination over-the-counter (OTC)&#xD;
             product that contains acetaminophen with an antihistamine, or OTC non-steroidal anti&#xD;
             inflammatory agent at a dose equal to or lower than that recommended on the package).&#xD;
             Vitamins and other nutritional supplements that are not newly introduced, ie, have&#xD;
             been taken for at least 30 days prior to enrolment, are not exclusionary&#xD;
&#xD;
          3. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months&#xD;
             prior to screening&#xD;
&#xD;
          4. Receipt of immunoglobulin or blood products within 6 months prior to screening&#xD;
&#xD;
          5. Receipt of any investigational product in the preceding 90 days or expected receipt of&#xD;
             investigational product during the period of study follow-up, or concurrent&#xD;
             participation in another interventional study Receipt of any vaccine within 7 days&#xD;
             prior to investigational product dosing or planned receipt within 61 days after&#xD;
             investigational product dosing except for influenza vaccine administered at least 28&#xD;
             days after dosing&#xD;
&#xD;
          6. Previous receipt of a mAb&#xD;
&#xD;
          7. Immunodeficiency due to illness, including human immunodeficiency virus (HIV)&#xD;
             infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2&#xD;
             weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6&#xD;
             months prior to screening. HIV testing must be negative at screening&#xD;
&#xD;
          8. History of allergic disease or reactions likely to be exacerbated by any component of&#xD;
             the investigational product&#xD;
&#xD;
          9. Either history of active infection with hepatitis B or C&#xD;
&#xD;
         10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine&#xD;
             above the upper limit of normal (ULN) or hemoglobin, white blood cell count, or&#xD;
             platelet count below the lower limit of normal at screening and in the predose blood&#xD;
             sample&#xD;
&#xD;
         11. Pregnant or nursing mother&#xD;
&#xD;
        13. History of alcohol or drug abuse within the past 2 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hasan S. Jafri, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>MedImmune LLC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martha Hernandez-Illas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MRA Clinical Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>June 27, 2017</results_first_submitted>
  <results_first_submitted_qc>November 22, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 13, 2018</results_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MEDI3902</keyword>
  <keyword>Safety,</keyword>
  <keyword>Pharmacokinetics,</keyword>
  <keyword>Healthy Volunteers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 131 participants were screened, of which 75 did not meet eligibility criteria and were considered as screen failures; and the remaining 56 participants were randomized into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received a single dose of placebo by intravenous (IV) infusion up to a maximum of 12 hours.</description>
        </group>
        <group group_id="P2">
          <title>MEDI3902 - Dose 1</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
        </group>
        <group group_id="P3">
          <title>MEDI3902 - Dose 2</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
        </group>
        <group group_id="P4">
          <title>MEDI3902 - Dose 3</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
        </group>
        <group group_id="P5">
          <title>MEDI3902 - Dose 4</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
        </group>
        <group group_id="B2">
          <title>MEDI3902 - Dose 1</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>MEDI3902 - Dose 2</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
        </group>
        <group group_id="B4">
          <title>MEDI3902 - Dose 3</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
        </group>
        <group group_id="B5">
          <title>MEDI3902 - Dose 4</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="15"/>
            <count group_id="B5" value="9"/>
            <count group_id="B6" value="56"/>
          </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="41.2" spread="10.9"/>
                    <measurement group_id="B2" value="34.0" spread="9.5"/>
                    <measurement group_id="B3" value="40.9" spread="11.8"/>
                    <measurement group_id="B4" value="40.3" spread="12.4"/>
                    <measurement group_id="B5" value="39.8" spread="13.1"/>
                    <measurement group_id="B6" value="40.3" spread="11.6"/>
                  </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="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="20"/>
                  </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)</title>
        <description>An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</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="14"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)</title>
        <description>An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event 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 that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.</description>
        <time_frame>Day 1 to Day 61</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)</title>
          <description>An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event 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 that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</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="14"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <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="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</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="14"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </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="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.</description>
        <time_frame>Day 1 to Day 7</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</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="14"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </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="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])</title>
        <description>Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
        <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])</title>
          <description>Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
          <units>micrograms*day/milliliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="694" spread="133"/>
                    <measurement group_id="O2" value="2149" spread="625"/>
                    <measurement group_id="O3" value="4246" spread="1117"/>
                    <measurement group_id="O4" value="6540" spread="1817"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose</title>
        <description>The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
        <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose</title>
          <description>The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
          <units>micrograms/milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" spread="6"/>
                    <measurement group_id="O2" value="207" spread="36"/>
                    <measurement group_id="O3" value="468" spread="134"/>
                    <measurement group_id="O4" value="838" spread="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Phase Elimination Half-life (t1/2)</title>
        <description>The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
        <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Phase Elimination Half-life (t1/2)</title>
          <description>The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</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="3"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="0.9"/>
                    <measurement group_id="O2" value="9.0" spread="2.1"/>
                    <measurement group_id="O3" value="9.4" spread="1.6"/>
                    <measurement group_id="O4" value="8.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution at Steady State (Vss)</title>
        <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
        <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution at Steady State (Vss)</title>
          <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
          <units>milliliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3412" spread="107"/>
                    <measurement group_id="O2" value="4022" spread="577"/>
                    <measurement group_id="O3" value="4326" spread="1246"/>
                    <measurement group_id="O4" value="4909" spread="1022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MEDI3902 Serum Clearance (CL) of MEDI3902</title>
        <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
        <time_frame>Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>MEDI3902 Serum Clearance (CL) of MEDI3902</title>
          <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
          <units>milliliters/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="371" spread="79"/>
                    <measurement group_id="O2" value="371" spread="101"/>
                    <measurement group_id="O3" value="373" spread="83"/>
                    <measurement group_id="O4" value="489" spread="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902</title>
        <description>Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented.</description>
        <time_frame>Days 1 (pre-dose), 15, 29, and 61</time_frame>
        <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
          </group>
          <group group_id="O2">
            <title>MEDI3902 - Dose 1</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>MEDI3902 - Dose 2</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>MEDI3902 - Dose 3</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>MEDI3902 - Dose 4</title>
            <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902</title>
          <description>Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented.</description>
          <population>Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.</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="14"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="1"/>
                    <measurement group_id="O5" value="0"/>
                  </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="14"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time of signature of informed consent through Day 61 of the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.</description>
        </group>
        <group group_id="E2">
          <title>MEDI3902 - Dose 1</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.</description>
        </group>
        <group group_id="E3">
          <title>MEDI3902 - Dose 2</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.</description>
        </group>
        <group group_id="E4">
          <title>MEDI3902 - Dose 3</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.</description>
        </group>
        <group group_id="E5">
          <title>MEDI3902 - Dose 4</title>
          <description>Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="4" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Periorbital contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dermatitis bullous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </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>Hasan S. Jafri, MD, Senior Director, Clinical Development</name_or_title>
      <organization>MedImmune LLC</organization>
      <phone>301-398-0000</phone>
      <email>jafrih@medimmune.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/NCT02255760
org study id: D5470C00002
nct id: NCT02255760
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study
      evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy
      adult subjects 18 to 60 years of age.
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study
      evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy
      adult subjects 18 to 60 years of age. Approximately 40 subjects will be enrolled across 4
      fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting
      a screening period of up to 28 days, 1 day of investigational product administration, and a
      60 day safety follow up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: Day 1 to Day 29
description: An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)
time frame: Day 1 to Day 61
description: An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event 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 that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.
measure: Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
time frame: Day 1 to Day 29
description: Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.
measure: Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
time frame: Day 1 to Day 7
description: Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.
measure: Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
description: Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
measure: Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose
time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
description: The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
measure: Terminal Phase Elimination Half-life (t1/2)
time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
description: The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
measure: Volume of Distribution at Steady State (Vss)
time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
measure: MEDI3902 Serum Clearance (CL) of MEDI3902
time frame: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
measure: Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
time frame: Days 1 (pre-dose), 15, 29, and 61
description: Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented.
arm group label: MEDI3902 - Dose 1
arm group type: Experimental
description: Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
arm group label: MEDI3902 - Dose 2
arm group type: Experimental
description: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
arm group label: MEDI3902 - Dose 3
arm group type: Experimental
description: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
arm group label: MEDI3902 - Dose 4
arm group type: Experimental
description: Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.
intervention type: Drug
intervention name: MEDI3902 - Dose 1
description: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
arm group label: MEDI3902 - Dose 1
other name: MEDI3902
intervention type: Drug
intervention name: MEDI3902 - Dose 2
description: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
arm group label: MEDI3902 - Dose 2
other name: MEDI3902
intervention type: Drug
intervention name: MEDI3902 - Dose 3
description: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
arm group label: MEDI3902 - Dose 3
other name: MEDI3902
intervention type: Drug
intervention name: MEDI3902 - Dose 4
description: Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
arm group label: MEDI3902 - Dose 4
other name: MEDI3902
intervention type: Other
intervention name: Placebo
description: Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hasan S. Jafri, M.D.
role: Study Director
affiliation: MedImmune LLC
last name: Martha Hernandez-Illas, MD
role: Principal Investigator
affiliation: MRA Clinical Research, LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Antibodies, Monoclonal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 