<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/NCT04503603</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-743-1003</org_study_id>
    <nct_id>NCT04503603</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda Development Center Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of&#xD;
      lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to&#xD;
      Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered&#xD;
      Intravenously in Healthy Adult Volunteer Subjects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Actual">December 23, 2020</completion_date>
  <primary_completion_date type="Actual">December 23, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters</measure>
    <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
    <description>Clinical laboratory assessment included hematology, clinical chemistry, coagulation, and urinalysis. Any changes in clinical laboratory results that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in laboratory values were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</measure>
    <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
    <description>Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature (oral). Any changes in vital signs that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in vital signs were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings</measure>
    <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
    <description>12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Any changes in ECG parameters that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab</measure>
    <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
    <description>AUC0-last for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab</measure>
    <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
    <description>AUC0-inf for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab</measure>
    <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
    <description>Cmax1 following the first IV dose for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab</measure>
    <time_frame>Pre-dose (Day 4) up to 2592 hours post-dose</time_frame>
    <description>Cmax2 following the second IV dose for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab</measure>
    <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
    <description>Tmax1 following the first IV dose for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab</measure>
    <time_frame>Pre-dose (Day 4) up to 2592 hours post-dose</time_frame>
    <description>Tmax2 following the second IV dose for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Half-Life (T1/2) of Lanadelumab in Plasma</measure>
    <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
    <description>T1/2 is defined as the time required for the concentration of the drug to reach half of its original value. T1/2 for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance (CL) of Lanadelumab in Plasma</measure>
    <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
    <description>Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab</measure>
    <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss for lanadelumab was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab</measure>
    <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
    <description>Lambda z of Lanadelumab was reported.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Lanadelumab 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of lanadelumab 300 mg intravenous (IV) infusion on Day 1 followed by second dose on Day 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participant will receive single dose of lanadelumab matching placebo (normal saline) IV infusion on Day 1 followed by second dose on Day 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanadelumab</intervention_name>
    <description>Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.</description>
    <arm_group_label>Lanadelumab 300 mg</arm_group_label>
    <other_name>TAK-743</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.&#xD;
&#xD;
          -  Continuous non-smoker who has not used nicotine-containing products for at least 30&#xD;
             days prior to the first dosing and throughout the study, based on participant&#xD;
             self-reporting.&#xD;
&#xD;
          -  Body mass index (BMI) greater than or equal to (&gt;=) 18.0 and less than or equal to&#xD;
             (&lt;=) 32.0 kilogram per square meter (kg/m^2) at screening.&#xD;
&#xD;
          -  Medically healthy with no clinically significant medical history, physical&#xD;
             examination, laboratory profiles, vital signs or electrocardiograms (ECGs), per the&#xD;
             investigator.&#xD;
&#xD;
          -  Male, or non-pregnant, non-lactating female who agrees to comply with any applicable&#xD;
             contraceptive requirements of the protocol or females of non-childbearing potential.&#xD;
&#xD;
          -  Understands the study procedures in the informed consent form (ICF) and be willing and&#xD;
             able to comply with the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is mentally or legally incapacitated or has significant emotional problems at the time&#xD;
             of the screening visit or expected during the conduct of the study.&#xD;
&#xD;
          -  History or presence of clinically significant medical or psychiatric condition or&#xD;
             disease per the investigator.&#xD;
&#xD;
          -  History of any illness that might confound the results of the study or poses an&#xD;
             additional risk to the participant by their participation in the study, per the&#xD;
             investigator.&#xD;
&#xD;
          -  History or presence of alcoholism or drug abuse within the past 2 years prior to the&#xD;
             first dosing per the investigator.&#xD;
&#xD;
          -  History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s)&#xD;
             or related compounds.&#xD;
&#xD;
          -  History or presence of any hematological, hepatic, respiratory, cardiovascular, renal,&#xD;
             neurological or psychiatric disease, gall bladder removal, or current or recurrent&#xD;
             disease that could affect the action, absorption, or disposition of the&#xD;
             investigational product, or clinically significant clinical or laboratory assessments&#xD;
             per the investigator.&#xD;
&#xD;
          -  Female participants with a positive pregnancy test or lactating.&#xD;
&#xD;
          -  Positive urine drug or alcohol results at screening.&#xD;
&#xD;
          -  Positive results at screening for human immunodeficiency virus (HIV), hepatitis B&#xD;
             surface antigen (HBsAg) or hepatitis C virus (HCV).&#xD;
&#xD;
          -  Supine blood pressure is less than 90/40 millimetre of mercury (mmHg) or greater than&#xD;
             140/90 mmHg at screening.&#xD;
&#xD;
          -  Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at&#xD;
             screening.&#xD;
&#xD;
          -  Orthostatic vital sign results with a decrease in systolic greater than (&gt;) 20 mmHg or&#xD;
             decrease in diastolic &gt; 10 mmHg and increase in pulse of &gt; 20 beats per minute.&#xD;
&#xD;
          -  QTcF interval is &gt; 450 milliseconds (msec) (males) or &gt; 470 msec (females) or ECG&#xD;
             findings are deemed abnormal with clinical significance at screening per the&#xD;
             investigator.&#xD;
&#xD;
          -  Estimated creatinine clearance less than (&lt;) 80 milliliters per minute (mL/min) at&#xD;
             screening.&#xD;
&#xD;
          -  Unable to refrain from or anticipates the use of any drug, including prescription and&#xD;
             non-prescription medications, herbal remedies, or vitamin supplements within 14 days&#xD;
             prior to the first dosing and throughout the study. Medication listed as part of&#xD;
             acceptable birth control methods will be allowed. Thyroid hormone replacement&#xD;
             medication may be permitted if the participant has been on the same stable dose for&#xD;
             the immediate 3 months prior to first study drug administration. After&#xD;
             randomization/dosing, a nonsteroidal anti-inflammatory drug may be administered at the&#xD;
             discretion of the investigator. Hormone replacement therapy will also be allowed if&#xD;
             the participant has been on the same stable dose for the immediate 3 months prior to&#xD;
             first study drug administration.&#xD;
&#xD;
          -  Has been on a diet incompatible with the on-study diet, per the investigator, within&#xD;
             the 30 days prior to the first dosing and throughout the study.&#xD;
&#xD;
          -  Donation of blood or significant blood loss within 56 days prior to the first dosing.&#xD;
&#xD;
          -  Plasma donation within 7 days prior to the first dosing.&#xD;
&#xD;
          -  Participation in another clinical study within 30 days or 5 half-lives prior to the&#xD;
             first dosing. The 30-day window or 5 half-lives will be derived from the date of the&#xD;
             last blood collection or dosing, whichever is later, in the previous study to Day 1 of&#xD;
             the current study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda Development Center Americas, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f9c5f6a2f8e61001ef3242d</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <results_first_submitted>December 14, 2021</results_first_submitted>
  <results_first_submitted_qc>December 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 7, 2022</results_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT04503603/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT04503603/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 1 investigative site in the United States between 10 August 2020 (first participant first visit) and 23 December 2020 (last participant last visit).</recruitment_details>
      <pre_assignment_details>A total of 12 healthy participants were enrolled and randomized to receive lanadelumab 300 milligrams (mg) or matching placebo in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lanadelumab 300 mg</title>
          <description>Participants received a single dose of lanadelumab 300 mg intravenous (IV) infusion on Day 1 followed by a second dose on Day 4.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received a single dose of lanadelumab matching placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </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>
      <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</population>
      <group_list>
        <group group_id="B1">
          <title>Lanadelumab 300 mg</title>
          <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.</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="9"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="12"/>
          </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="34.3" spread="11.73"/>
                    <measurement group_id="B2" value="42.0" spread="10.44"/>
                    <measurement group_id="B3" value="36.3" spread="11.48"/>
                  </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="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="11"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.</description>
        <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
        <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.</description>
          <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</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="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters</title>
        <description>Clinical laboratory assessment included hematology, clinical chemistry, coagulation, and urinalysis. Any changes in clinical laboratory results that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in laboratory values were reported.</description>
        <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
        <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters</title>
          <description>Clinical laboratory assessment included hematology, clinical chemistry, coagulation, and urinalysis. Any changes in clinical laboratory results that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in laboratory values were reported.</description>
          <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</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="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</title>
        <description>Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature (oral). Any changes in vital signs that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in vital signs were reported.</description>
        <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
        <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</title>
          <description>Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature (oral). Any changes in vital signs that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in vital signs were reported.</description>
          <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</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="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings</title>
        <description>12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Any changes in ECG parameters that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.</description>
        <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
        <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings</title>
          <description>12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Any changes in ECG parameters that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.</description>
          <population>The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.</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="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab</title>
        <description>AUC0-last for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
        <population>The pharmacokinetic (PK) analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab</title>
          <description>AUC0-last for lanadelumab was reported.</description>
          <population>The pharmacokinetic (PK) analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>hour*microgram per milliliter (h*mcg/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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32955" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab</title>
        <description>AUC0-inf for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab</title>
          <description>AUC0-inf for lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>h*mcg/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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33305" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab</title>
        <description>Cmax1 following the first IV dose for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab</title>
          <description>Cmax1 following the first IV dose for lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>microgram per milliliter (mcg/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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.6" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab</title>
        <description>Cmax2 following the second IV dose for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 4) up to 2592 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab</title>
          <description>Cmax2 following the second IV dose for lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>mcg/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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab</title>
        <description>Tmax1 following the first IV dose for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab</title>
          <description>Tmax1 following the first IV dose for lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" lower_limit="2.00" upper_limit="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab</title>
        <description>Tmax2 following the second IV dose for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 4) up to 2592 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab</title>
          <description>Tmax2 following the second IV dose for lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.03" lower_limit="72.92" upper_limit="76.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal Half-Life (T1/2) of Lanadelumab in Plasma</title>
        <description>T1/2 is defined as the time required for the concentration of the drug to reach half of its original value. T1/2 for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Half-Life (T1/2) of Lanadelumab in Plasma</title>
          <description>T1/2 is defined as the time required for the concentration of the drug to reach half of its original value. T1/2 for lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3" lower_limit="13.7" upper_limit="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clearance (CL) of Lanadelumab in Plasma</title>
        <description>Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance (CL) of Lanadelumab in Plasma</title>
          <description>Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL for lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>milliliter per hour (mL/h)</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab</title>
        <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss for lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab</title>
          <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss for lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>milliliter (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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8070" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab</title>
        <description>Lambda z of Lanadelumab was reported.</description>
        <time_frame>Pre-dose (Day 1) up to 2664 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanadelumab 300 mg</title>
            <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
          </group>
        </group_list>
        <measure>
          <title>First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab</title>
          <description>Lambda z of Lanadelumab was reported.</description>
          <population>The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.</population>
          <units>Per hour (/h)</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.90" spread="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of study treatment up to the end of study (Day 112)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lanadelumab 300 mg</title>
          <description>Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.</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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <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="7" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </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>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>TrialDisclosures@takeda.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/NCT04503603
org study id: TAK-743-1003
nct id: NCT04503603
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of
      lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.
A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to
      Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered
      Intravenously in Healthy Adult Volunteer Subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
time frame: From the first dose of study treatment up to the end of study (Day 112)
description: An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
time frame: From the first dose of study treatment up to the end of study (Day 112)
description: Clinical laboratory assessment included hematology, clinical chemistry, coagulation, and urinalysis. Any changes in clinical laboratory results that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in laboratory values were reported.
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
time frame: From the first dose of study treatment up to the end of study (Day 112)
description: Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature (oral). Any changes in vital signs that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in vital signs were reported.
measure: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
time frame: From the first dose of study treatment up to the end of study (Day 112)
description: 12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Any changes in ECG parameters that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
measure: AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab
time frame: Pre-dose (Day 1) up to 2664 hours post-dose
description: AUC0-last for lanadelumab was reported.
measure: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab
time frame: Pre-dose (Day 1) up to 2664 hours post-dose
description: AUC0-inf for lanadelumab was reported.
measure: Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab
time frame: Pre-dose (Day 1) up to 2664 hours post-dose
description: Cmax1 following the first IV dose for lanadelumab was reported.
measure: Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab
time frame: Pre-dose (Day 4) up to 2592 hours post-dose
description: Cmax2 following the second IV dose for lanadelumab was reported.
measure: Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab
time frame: Pre-dose (Day 1) up to 2664 hours post-dose
description: Tmax1 following the first IV dose for lanadelumab was reported.
measure: Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab
time frame: Pre-dose (Day 4) up to 2592 hours post-dose
description: Tmax2 following the second IV dose for lanadelumab was reported.
measure: Terminal Half-Life (T1/2) of Lanadelumab in Plasma
time frame: Pre-dose (Day 1) up to 2664 hours post-dose
description: T1/2 is defined as the time required for the concentration of the drug to reach half of its original value. T1/2 for lanadelumab was reported.
measure: Clearance (CL) of Lanadelumab in Plasma
time frame: Pre-dose (Day 1) up to 2664 hours post-dose
description: Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL for lanadelumab was reported.
measure: Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab
time frame: Pre-dose (Day 1) up to 2664 hours post-dose
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss for lanadelumab was reported.
measure: First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab
time frame: Pre-dose (Day 1) up to 2664 hours post-dose
description: Lambda z of Lanadelumab was reported.
arm group label: Lanadelumab 300 mg
arm group type: Experimental
description: Participants will receive single dose of lanadelumab 300 mg intravenous (IV) infusion on Day 1 followed by second dose on Day 4.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participant will receive single dose of lanadelumab matching placebo (normal saline) IV infusion on Day 1 followed by second dose on Day 4.
intervention type: Drug
intervention name: Lanadelumab
description: Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.
arm group label: Lanadelumab 300 mg
other name: TAK-743
intervention type: Other
intervention name: Placebo
description: Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Takeda Development Center Americas, Inc.
facility: 
country: United States
url: https://clinicaltrials.takeda.com/study-detail/5f9c5f6a2f8e61001ef3242d
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 