<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/NCT02968914</url>
  </required_header>
  <id_info>
    <org_study_id>D3250C00030</org_study_id>
    <nct_id>NCT02968914</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers</brief_title>
  <official_title>A Multicenter, Randomized, Open-Label, Parallel Group Phase 1 Pharmacokinetic Comparability Study of Benralizumab Administrated Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable&#xD;
      drug exposure following Subcutaneous benralizumab administration by using accessorized&#xD;
      pre-filled syringe (APFS) or autoinjector (AI) devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A study of descriptive comparison of benralizumab PK by weight and injection site.&#xD;
&#xD;
      This study will be a multicenter, randomized, open-label, parallel group Phase 1 study&#xD;
      designed to compare benralizumab PK exposure in healthy subjects following single&#xD;
      subcutaneous (SC) administration of fixed 30 mg dose of benralizumab by using APFS and&#xD;
      single-use AI. Eligible subjects will be healthy subjects aged 18 to 55 years, with a body&#xD;
      weight of 55 to 100 kg and a body mass index of 18 to 29.9 kg/m2 . A total of 180 subjects&#xD;
      will be randomized. Randomization will be stratified by weight group (55 to 69.9 kg, 70 to&#xD;
      84.9 kg and 85 to 100 kg), and within each of the 3 weight groups, subjects will be&#xD;
      randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS or AI) with injection&#xD;
      site (upper arm, abdomen or thigh), presented in Table 1. This study will be performed at 2&#xD;
      study centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">July 13, 2017</completion_date>
  <primary_completion_date type="Actual">July 13, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve From Zero to Infinity (AUCinf)</measure>
    <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
    <description>To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
    <description>To compare the AUClast following single SC administration of Benralizumab by using APFS or AI devices</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Concentration (Cmax)</measure>
    <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
    <description>To compare the Cmax following single SC administration of Benralizumab by using APFS or AI devices</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time When Maximum Concentration is Observed (Tmax)</measure>
    <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
    <description>To evaluate the Tmax of Benralizumab administered to various injection sites and in subjects with different body weight ranges</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Half-life (t½)</measure>
    <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
    <description>To evaluate the t½ of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Extravascular Clearance (CL/F)</measure>
    <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
    <description>To evaluate the CL/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)</measure>
    <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
    <description>To evaluate the Vz/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>At predose and 2 h postdose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
    <description>To evaluate safety and tolerability of Benralizumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antidrug Antibody (ADA) Status</measure>
    <time_frame>At predose (Day 1), Days 29 and 57</time_frame>
    <description>To evaluate the immunogenicity of Benralizumab</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Asthma</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Benralizumab by Accessorized Pre-Filled Syringe</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug administration by Accessorized Pre-Filled Syringe. A total of 180 subjects will be randomized and will be stratified by weight group (55 to 69.9 kg, 70 to 84.9 kg and 85 to 100 kg). Within each of the 3 weight groups, subjects will be randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS) with injection site (upper arm, abdomen or thigh)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benralizumab by Autoinjector</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Drug administration by Autoinjector A total of 180 subjects will be randomized and will be stratified by weight group (55 to 69.9 kg, 70 to 84.9 kg and 85 to 100 kg). Within each of the 3 weight groups, subjects will be randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS) with injection site (upper arm, abdomen or thigh)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Benralizumab</intervention_name>
    <description>A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.</description>
    <arm_group_label>Benralizumab by Accessorized Pre-Filled Syringe</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Benralizumab</intervention_name>
    <description>A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.</description>
    <arm_group_label>Benralizumab by Autoinjector</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects of non-child-bearing potential aged 18 to 55 years&#xD;
             (inclusive) with suitable veins for cannulation or repeated venipuncture.&#xD;
&#xD;
          -  Females must be non pregnant,non lactating and non-child-bearing potential, confirmed&#xD;
             at screening&#xD;
&#xD;
          -  Sexually active male willingness to use contraception&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 55 kg and&#xD;
             no more than 100 kg inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any clinically significant disease, severe allergy/anaphylaxis to any&#xD;
             biologic therapy, Guillain-Barré syndrome, smoking and alcohol or drug abuse&#xD;
&#xD;
          -  Diagnosis of helminth parasitic infection and acute upper or lower respiratory&#xD;
             infections&#xD;
&#xD;
          -  Disorders related to cardiovascular, gastrointestinal, hepatic, renal, neurological,&#xD;
             musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or&#xD;
             major physical impairment&#xD;
&#xD;
          -  Alanine aminotransferase/aspartate aminotransferase level ≥1.5 times the upper limit&#xD;
             of normal&#xD;
&#xD;
          -  White blood cell count and neutrophils &lt; lower limit of normal&#xD;
&#xD;
          -  Any clinically significant illness, medical/surgical procedure, or trauma within 4&#xD;
             weeks of the first administration of Investigational medicinal product (IMP)&#xD;
&#xD;
          -  Positive result for serum hepatitis B surface antigen or anti-Hemoglobin C (anti-HBc)&#xD;
             antibody, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
          -  Intake of new chemical entity (not been approved for marketing) within 3 months of the&#xD;
             first administration of investigational product&#xD;
&#xD;
          -  Plasma donation within 1 month of screening or any blood donation/loss more than 500&#xD;
             mL during the 3 months prior to screening&#xD;
&#xD;
          -  Receipt of immunoglobulin or blood products within 30 days prior to the date informed&#xD;
             consent&#xD;
&#xD;
          -  Receipt of any marketed (e.g., omalizumab, mepolizumab etc.) or investigational&#xD;
             biologic within 4 months or 5 half-lives prior to the date informed consent&#xD;
&#xD;
          -  Receipt of live attenuated vaccines 30 days prior to randomization on Day 1&#xD;
&#xD;
          -  Current malignancy, or history of malignancy except (basal cell carcinoma, localized&#xD;
             squamous cell carcinoma of the skin or in situ carcinoma of the cervix)&#xD;
&#xD;
          -  Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks&#xD;
             prior to the first administration of IMP.&#xD;
&#xD;
          -  Use of antacids, analgesics (except paracetamol/acetaminophen), herbal remedies,&#xD;
             mega-dose vitamins (20 to 600 times the recommended daily dose) and minerals during&#xD;
             the 2 weeks prior to the first administration of IMP or longer&#xD;
&#xD;
          -  Previous receipt of received benralizumab&#xD;
&#xD;
          -  Any ongoing or recent minor medical complaints&#xD;
&#xD;
          -  Vulnerable subjects, e.g., kept in detention, protected adults under guardianship,&#xD;
             trusteeship, or committed to an institution by governmental or juridical order&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Rainard Fuhr, Medicine</last_name>
    <role>Principal Investigator</role>
    <affiliation>PAREXEL Early Phase Clinical Unit Berlin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Pablo Forte-Soto</last_name>
    <role>Principal Investigator</role>
    <affiliation>PAREXEL Early Phase Clinical Unit London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Harrow</city>
        <zip>HA1 3UJ</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=4091&amp;filename=230172_D3250C00030_SAP_Final_21-Sep-2018.pdf</url>
    <description>SAP</description>
  </link>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=4091&amp;filename=230172_D3250C00030_Protocol_Final_21-Sep-2018.pdf</url>
    <description>SP</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>October 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>January 2, 2019</results_first_submitted>
  <results_first_submitted_qc>July 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 5, 2019</results_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Chronic Obstructive pulmonary Disease</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Healthy volunteers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Benralizumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02968914/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02968914/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects who met all the inclusion and none of the exclusion criteria were enrolled at PAREXEL Early Phase Clinical Unit in Berlin and London.</recruitment_details>
      <pre_assignment_details>Subjects attended a Screening Visit within 28 days before receiving their first dose of Benralizumab. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study-related procedures.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Benralizumab 30mg Autoinjector (AI)</title>
          <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
        </group>
        <group group_id="P2">
          <title>Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)</title>
          <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Benralizumab 30mg Autoinjector (AI)</title>
          <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
        </group>
        <group group_id="B2">
          <title>Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)</title>
          <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
        </group>
        <group group_id="B3">
          <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="90"/>
            <count group_id="B2" value="90"/>
            <count group_id="B3" value="180"/>
          </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="40.8" spread="10.8"/>
                    <measurement group_id="B2" value="41.1" spread="11.1"/>
                    <measurement group_id="B3" value="40.9" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve From Zero to Infinity (AUCinf)</title>
        <description>To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices</description>
        <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
        <population>The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve From Zero to Infinity (AUCinf)</title>
          <description>To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices</description>
          <population>The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.</population>
          <units>day·ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72210" spread="29.7"/>
                    <measurement group_id="O2" value="76220" spread="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Geometric mean ratio (%)</param_type>
            <param_value>94.46</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>88.16</ci_lower_limit>
            <ci_upper_limit>101.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)</title>
        <description>To compare the AUClast following single SC administration of Benralizumab by using APFS or AI devices</description>
        <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
        <population>The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)</title>
          <description>To compare the AUClast following single SC administration of Benralizumab by using APFS or AI devices</description>
          <population>The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.</population>
          <units>day·ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60560" spread="27.3"/>
                    <measurement group_id="O2" value="65230" spread="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Geometric mean ratio (%)</param_type>
            <param_value>92.83</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>87.41</ci_lower_limit>
            <ci_upper_limit>98.58</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration (Cmax)</title>
        <description>To compare the Cmax following single SC administration of Benralizumab by using APFS or AI devices</description>
        <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
        <population>The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax)</title>
          <description>To compare the Cmax following single SC administration of Benralizumab by using APFS or AI devices</description>
          <population>The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2096" spread="32.7"/>
                    <measurement group_id="O2" value="2269" spread="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Geometric mean ratio (%)</param_type>
            <param_value>92.34</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>86.34</ci_lower_limit>
            <ci_upper_limit>98.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time When Maximum Concentration is Observed (Tmax)</title>
        <description>To evaluate the Tmax of Benralizumab administered to various injection sites and in subjects with different body weight ranges</description>
        <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
        <population>The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Time When Maximum Concentration is Observed (Tmax)</title>
          <description>To evaluate the Tmax of Benralizumab administered to various injection sites and in subjects with different body weight ranges</description>
          <population>The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdomen 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.59" lower_limit="2.97" upper_limit="7.04"/>
                    <measurement group_id="O2" value="6.06" lower_limit="4.00" upper_limit="14.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.98" lower_limit="3.98" upper_limit="14.00"/>
                    <measurement group_id="O2" value="5.98" lower_limit="2.95" upper_limit="14.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.06" lower_limit="3.95" upper_limit="7.11"/>
                    <measurement group_id="O2" value="6.96" lower_limit="3.99" upper_limit="7.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="2.97" upper_limit="7.01"/>
                    <measurement group_id="O2" value="4.52" lower_limit="2.94" upper_limit="7.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.05" lower_limit="2.98" upper_limit="6.90"/>
                    <measurement group_id="O2" value="3.52" lower_limit="2.95" upper_limit="7.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.59" lower_limit="2.94" upper_limit="13.95"/>
                    <measurement group_id="O2" value="4.03" lower_limit="2.98" upper_limit="6.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.97" lower_limit="3.97" upper_limit="14.02"/>
                    <measurement group_id="O2" value="4.96" lower_limit="3.02" upper_limit="14.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" lower_limit="5.01" upper_limit="14.03"/>
                    <measurement group_id="O2" value="5.02" lower_limit="2.99" upper_limit="8.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" lower_limit="3.09" upper_limit="14.03"/>
                    <measurement group_id="O2" value="6.97" lower_limit="1.02" upper_limit="14.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Half-life (t½)</title>
        <description>To evaluate the t½ of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
        <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
        <population>The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Half-life (t½)</title>
          <description>To evaluate the t½ of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
          <population>The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.</population>
          <units>Days</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdomen 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.83" spread="24.9"/>
                    <measurement group_id="O2" value="20.15" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.22" spread="21.0"/>
                    <measurement group_id="O2" value="17.43" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.59" spread="19.9"/>
                    <measurement group_id="O2" value="21.04" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.58" spread="20.6"/>
                    <measurement group_id="O2" value="19.72" spread="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.93" spread="23.4"/>
                    <measurement group_id="O2" value="18.28" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.02" spread="19.9"/>
                    <measurement group_id="O2" value="17.30" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.46" spread="13.6"/>
                    <measurement group_id="O2" value="17.30" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.54" spread="14.0"/>
                    <measurement group_id="O2" value="20.16" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.01" spread="26.9"/>
                    <measurement group_id="O2" value="19.42" spread="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Extravascular Clearance (CL/F)</title>
        <description>To evaluate the CL/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
        <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
        <population>The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Extravascular Clearance (CL/F)</title>
          <description>To evaluate the CL/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
          <population>The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.</population>
          <units>mL/day</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdomen 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="388.8" spread="34.3"/>
                    <measurement group_id="O2" value="388.9" spread="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="462.9" spread="29.5"/>
                    <measurement group_id="O2" value="508.9" spread="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="504.6" spread="18.3"/>
                    <measurement group_id="O2" value="402.7" spread="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="350.1" spread="32.6"/>
                    <measurement group_id="O2" value="281.1" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="393.7" spread="29.6"/>
                    <measurement group_id="O2" value="325.9" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="378.2" spread="26.8"/>
                    <measurement group_id="O2" value="406.0" spread="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="345.8" spread="24.7"/>
                    <measurement group_id="O2" value="455.2" spread="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="429.4" spread="19.5"/>
                    <measurement group_id="O2" value="366.1" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="532.6" spread="21.7"/>
                    <measurement group_id="O2" value="471.6" spread="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)</title>
        <description>To evaluate the Vz/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
        <time_frame>At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
        <population>The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)</title>
          <description>To evaluate the Vz/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.</description>
          <population>The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.</population>
          <units>Liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdomen 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.56" spread="28.0"/>
                    <measurement group_id="O2" value="11.30" spread="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.50" spread="30.4"/>
                    <measurement group_id="O2" value="12.79" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.26" spread="25.0"/>
                    <measurement group_id="O2" value="12.22" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.386" spread="18.2"/>
                    <measurement group_id="O2" value="7.999" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.32" spread="23.5"/>
                    <measurement group_id="O2" value="8.596" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thigh 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.38" spread="20.2"/>
                    <measurement group_id="O2" value="10.13" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 55.0 to 69.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.21" spread="21.2"/>
                    <measurement group_id="O2" value="11.36" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 70.0 to 84.9 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.72" spread="23.6"/>
                    <measurement group_id="O2" value="10.65" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper arm 85.0 to 100.0 kg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.61" spread="23.0"/>
                    <measurement group_id="O2" value="13.21" spread="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>To evaluate safety and tolerability of Benralizumab</description>
        <time_frame>At predose and 2 h postdose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
        <population>Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>To evaluate safety and tolerability of Benralizumab</description>
          <population>Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.</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="90"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antidrug Antibody (ADA) Status</title>
        <description>To evaluate the immunogenicity of Benralizumab</description>
        <time_frame>At predose (Day 1), Days 29 and 57</time_frame>
        <population>Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Benralizumab 30mg AI</title>
            <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Benralizumab 30mg AFPS</title>
            <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Antidrug Antibody (ADA) Status</title>
          <description>To evaluate the immunogenicity of Benralizumab</description>
          <population>Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.</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="90"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA prevalence (positive at any visit)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA incidence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Benralizumab 30mg Autoinjector (AI)</title>
          <description>All randomized subjects received 30mg Benralizumab by AI under fasted conditions.</description>
        </group>
        <group group_id="E2">
          <title>Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)</title>
          <description>All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.</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="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="50" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Injection site hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Myringitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Traumatic haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Tendon discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hypertonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Listless</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Skin fissures</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="90"/>
              </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>All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>AstraZeneca Clinical Study Information Center</name_or_title>
      <organization>AstraZeneca Clinical Study Information Center</organization>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.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/NCT02968914
org study id: D3250C00030
nct id: NCT02968914
lead sponsor: 
collaborator: 
has dmc: No
An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable
      drug exposure following Subcutaneous benralizumab administration by using accessorized
      pre-filled syringe (APFS) or autoinjector (AI) devices.
A study of descriptive comparison of benralizumab PK by weight and injection site.

      This study will be a multicenter, randomized, open-label, parallel group Phase 1 study
      designed to compare benralizumab PK exposure in healthy subjects following single
      subcutaneous (SC) administration of fixed 30 mg dose of benralizumab by using APFS and
      single-use AI. Eligible subjects will be healthy subjects aged 18 to 55 years, with a body
      weight of 55 to 100 kg and a body mass index of 18 to 29.9 kg/m2 . A total of 180 subjects
      will be randomized. Randomization will be stratified by weight group (55 to 69.9 kg, 70 to
      84.9 kg and 85 to 100 kg), and within each of the 3 weight groups, subjects will be
      randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS or AI) with injection
      site (upper arm, abdomen or thigh), presented in Table 1. This study will be performed at 2
      study centers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Concentration-time Curve From Zero to Infinity (AUCinf)
time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
description: To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices
measure: Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
description: To compare the AUClast following single SC administration of Benralizumab by using APFS or AI devices
measure: Maximum Observed Concentration (Cmax)
time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
description: To compare the Cmax following single SC administration of Benralizumab by using APFS or AI devices
measure: Time When Maximum Concentration is Observed (Tmax)
time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
description: To evaluate the Tmax of Benralizumab administered to various injection sites and in subjects with different body weight ranges
measure: Terminal Half-life (t½)
time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
description: To evaluate the t½ of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
measure: Apparent Extravascular Clearance (CL/F)
time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
description: To evaluate the CL/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
measure: Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
description: To evaluate the Vz/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
measure: Number of Participants With Adverse Events
time frame: At predose and 2 h postdose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
description: To evaluate safety and tolerability of Benralizumab
measure: Antidrug Antibody (ADA) Status
time frame: At predose (Day 1), Days 29 and 57
description: To evaluate the immunogenicity of Benralizumab
arm group label: Benralizumab by Accessorized Pre-Filled Syringe
arm group type: Active Comparator
description: Drug administration by Accessorized Pre-Filled Syringe. A total of 180 subjects will be randomized and will be stratified by weight group (55 to 69.9 kg, 70 to 84.9 kg and 85 to 100 kg). Within each of the 3 weight groups, subjects will be randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS) with injection site (upper arm, abdomen or thigh)
arm group label: Benralizumab by Autoinjector
arm group type: Other
description: Drug administration by Autoinjector A total of 180 subjects will be randomized and will be stratified by weight group (55 to 69.9 kg, 70 to 84.9 kg and 85 to 100 kg). Within each of the 3 weight groups, subjects will be randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS) with injection site (upper arm, abdomen or thigh)
intervention type: Biological
intervention name: Benralizumab
description: A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.
arm group label: Benralizumab by Accessorized Pre-Filled Syringe
intervention type: Biological
intervention name: Benralizumab
description: A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.
arm group label: Benralizumab by Autoinjector
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Rainard Fuhr, Medicine
role: Principal Investigator
affiliation: PAREXEL Early Phase Clinical Unit Berlin
last name: Dr. Pablo Forte-Soto
role: Principal Investigator
affiliation: PAREXEL Early Phase Clinical Unit London
facility: 
facility: 
country: Germany
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4091&filename=230172_D3250C00030_SAP_Final_21-Sep-2018.pdf
description: SAP
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4091&filename=230172_D3250C00030_Protocol_Final_21-Sep-2018.pdf
description: SP
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Benralizumab
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 