<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/NCT01660230</url>
  </required_header>
  <id_info>
    <org_study_id>ZZ-3K3A-001</org_study_id>
    <secondary_id>2011-000793-60</secondary_id>
    <nct_id>NCT01660230</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC, a Recombinant Variant of Human Activated Protein C (APC), in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ZZ Biotech, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ZZ Biotech, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and&#xD;
      multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, sequential-cohort, double-blind, placebo-controlled, single- and&#xD;
      multiple-ascending dose study. Eligible adult subjects will be assigned sequentially to 1 of&#xD;
      10 cohorts, at successively higher single doses, followed by successively higher multiple&#xD;
      doses.&#xD;
&#xD;
      Single IV Doses: 5 subjects per cohort, aged 18-55, will be randomized in a 4:1 manner to&#xD;
      receive active drug (6, 30, 90, 180, 360, and TBD µg/kg) or to receive matching placebo&#xD;
      (Cohorts 1-6).&#xD;
&#xD;
      Multiple IV Doses: 8 subjects per cohort, aged 18-55, will be randomized in a 3:1 manner to&#xD;
      receive active drug (90, 180, 360, and TBD µg/kg) or to receive matching placebo every 12&#xD;
      hours for 5 doses (Cohorts 7-10).&#xD;
&#xD;
      Single-Dose Cohorts Subjects receiving a single dose will be confined in a Phase 1 unit for&#xD;
      12 hours prior to dosing, during dosing, and for 24 hours after dosing (Study Day 1-2) for&#xD;
      observation and PK sampling. Subjects will return on Study Day 4 (~72 hours after infusion)&#xD;
      and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call will be&#xD;
      made to subjects to collect AEs that occur within 28-days of the dose.&#xD;
&#xD;
      Multiple-Dose Cohorts Subjects receiving multiple doses will be confined in a Phase 1 unit&#xD;
      for 12 hours prior to dosing through 24 hours following the last dose (Study Day 1-4) for&#xD;
      observation and PK sampling. Subjects will return on Study Day 6 (~72 hours after last&#xD;
      infusion) and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call&#xD;
      will be made to subjects to collect AEs that occur within 28-days of the last dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.</measure>
    <time_frame>Day 4 for single-dose cohorts</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.</measure>
    <time_frame>Day 6 for multiple-dose cohorts</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t1/2) of 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Clearance (CL) of 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
    <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
    <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
    <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
    <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t1/2) of 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
    <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Clearance (CL) of 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
    <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis</measure>
    <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
    <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>6 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>180 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>360 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TBD µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 6: TBD (not to exceed 720) µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90 µg/kg 3K3A-APC, q12h for 5 doses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>180 µg/kg 3K3A-APC, q12h for 5 doses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>360 µg/kg 3K3A-APC, q12h for 5 doses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TBD µg/kg 3K3A-APC, q12h for 5 doses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 10: TBD (not to exceed 720) µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching Placebo, 0.9% NaCl in water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>3K3A-APC, diluted in 0.9% sodium chloride in water</intervention_name>
    <arm_group_label>180 µg/kg 3K3A-APC, q12h for 5 doses</arm_group_label>
    <arm_group_label>180 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_label>30 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_label>360 µg/kg 3K3A-APC, q12h for 5 doses</arm_group_label>
    <arm_group_label>360 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_label>6 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_label>90 µg/kg 3K3A-APC, q12h for 5 doses</arm_group_label>
    <arm_group_label>90 µg/kg 3K3A-APC, single-dose</arm_group_label>
    <arm_group_label>TBD µg/kg 3K3A-APC, q12h for 5 doses</arm_group_label>
    <arm_group_label>TBD µg/kg 3K3A-APC, single-dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% NaCl in water</intervention_name>
    <arm_group_label>Matching Placebo, 0.9% NaCl in water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males or non-pregnant, non-lactating females&#xD;
&#xD;
          2. Both men and women of child-bearing potential (i.e., not surgically sterile or&#xD;
             post-menopausal defined as age &gt; 40 years without menses for ≥ 2 years) must agree to&#xD;
             use a barrier method of contraception plus a spermicide throughout the study.&#xD;
&#xD;
          3. Age 18 to 55 years, inclusive&#xD;
&#xD;
          4. Body Mass Index (BMI) of 19 to 30 kg/m2, inclusive (see APPENDIX B)&#xD;
&#xD;
          5. Willing and able to complete all study visits&#xD;
&#xD;
          6. Agreement to abstain from smoking and drinking alcoholic beverages from 48 hours prior&#xD;
             to randomization through last Study Day (15)&#xD;
&#xD;
          7. Signed informed consent form (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any medical problem for which the subject is being evaluated and/or treated&#xD;
&#xD;
          2. Activated partial thromboplastin time (aPTT) greater than upper limit of normal (ULN)&#xD;
&#xD;
          3. Platelet count &lt; 125,000 cells/mm3&#xD;
&#xD;
          4. International Normalized Ratio (INR) &gt; 1.3&#xD;
&#xD;
          5. Any other clinically significant abnormalities in laboratory values (chemistries,&#xD;
             hematology, coagulation studies, and urinalysis - see APPENDIX C)&#xD;
&#xD;
          6. Clinically significant abnormalities on electrocardiogram (ECG)&#xD;
&#xD;
          7. Positive serum βHCG pregnancy test at screening or on Study Day -1 (for all women,&#xD;
             regardless of child-bearing potential)&#xD;
&#xD;
          8. Positive urine drug screen at screening or on Study Day -1 (see APPENDIX C)&#xD;
&#xD;
          9. Positive blood test for hepatitis B surface antigen, hepatitis C antibody, or HIV&#xD;
             antibody&#xD;
&#xD;
         10. Known family history of bleeding or blood clotting disorders&#xD;
&#xD;
         11. History of bleeding diathesis&#xD;
&#xD;
         12. History of liver disease with ongoing coagulopathy&#xD;
&#xD;
         13. Use of any prescription or non-prescription medications or supplements within 7 days&#xD;
             prior to Study Day -1, excluding hormonal contraceptives&#xD;
&#xD;
         14. Use of anticoagulant medication within 14 days prior to Study Day -1&#xD;
&#xD;
         15. Major surgery within 60 days prior to Study Day -1&#xD;
&#xD;
         16. Receipt of an investigational drug within 30 days prior to Study Day -1&#xD;
&#xD;
         17. Donation of blood or plasma within 30 days prior to Study Day -1&#xD;
&#xD;
         18. Any other condition, that in the opinion of the Site Investigator, may adversely&#xD;
             affect the safety of the subject, the subject's ability to complete the study, or the&#xD;
             outcome of the study&#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>Patrick D Lyden, MD, FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Howard Levy, MD, PhD, MMM</last_name>
    <role>Study Director</role>
    <affiliation>ZZ Biotech, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Privatklinik Leech</name>
      <address>
        <city>Graz</city>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <results_first_submitted>February 27, 2014</results_first_submitted>
  <results_first_submitted_qc>February 27, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 10, 2014</results_first_posted>
  <last_update_submitted>January 9, 2018</last_update_submitted>
  <last_update_submitted_qc>January 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>APC, 3K3A, 3K3A-APC, volunteer, healthy</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>6 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P2">
          <title>30 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P3">
          <title>90 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P4">
          <title>180 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P5">
          <title>360 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P6">
          <title>720 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P7">
          <title>540 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P8">
          <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P9">
          <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P10">
          <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P11">
          <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="P12">
          <title>Matching Placebo, 0.9% NaCl in Water</title>
          <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>6 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B2">
          <title>30 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B3">
          <title>90 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B4">
          <title>180 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B5">
          <title>360 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B6">
          <title>720 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B7">
          <title>540 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B8">
          <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B9">
          <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B10">
          <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B11">
          <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="B12">
          <title>Matching Placebo, 0.9% NaCl in Water</title>
          <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
        </group>
        <group group_id="B13">
          <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="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="4"/>
            <count group_id="B6" value="2"/>
            <count group_id="B7" value="4"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="6"/>
            <count group_id="B11" value="6"/>
            <count group_id="B12" value="14"/>
            <count group_id="B13" value="64"/>
          </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="27.25" spread="10.59"/>
                    <measurement group_id="B2" value="28.50" spread="9.26"/>
                    <measurement group_id="B3" value="23.75" spread="2.36"/>
                    <measurement group_id="B4" value="24.00" spread="2.58"/>
                    <measurement group_id="B5" value="28.25" spread="10.11"/>
                    <measurement group_id="B6" value="36.00" spread="9.90"/>
                    <measurement group_id="B7" value="23.75" spread="2.75"/>
                    <measurement group_id="B8" value="27.00" spread="3.58"/>
                    <measurement group_id="B9" value="24.50" spread="3.78"/>
                    <measurement group_id="B10" value="27.50" spread="13.00"/>
                    <measurement group_id="B11" value="25.67" spread="5.28"/>
                    <measurement group_id="B12" value="29.14" spread="8.08"/>
                    <measurement group_id="B13" value="27.03" spread="7.39"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="8"/>
                    <measurement group_id="B13" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="4"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="13"/>
                    <measurement group_id="B13" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="14"/>
                    <measurement group_id="B13" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.</title>
        <time_frame>Day 4 for single-dose cohorts</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.</title>
          <population>All 'single-dose' subjects who received at least one dose of study treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.</title>
        <time_frame>Day 6 for multiple-dose cohorts</time_frame>
        <population>All 'multiple-dose' subjects who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.</title>
          <population>All 'multiple-dose' subjects who received at least one dose of study treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="248" spread="64.1"/>
                    <measurement group_id="O3" value="745" spread="33.2"/>
                    <measurement group_id="O4" value="1423" spread="131"/>
                    <measurement group_id="O5" value="3562" spread="512"/>
                    <measurement group_id="O6" value="6115" spread="522"/>
                    <measurement group_id="O7" value="4428" spread="462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>hour (from start of infusion)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.250" lower_limit="0.250" upper_limit="0.250"/>
                    <measurement group_id="O3" value="0.250" lower_limit="0.233" upper_limit="0.250"/>
                    <measurement group_id="O4" value="0.250" lower_limit="0.250" upper_limit="0.333"/>
                    <measurement group_id="O5" value="0.333" lower_limit="0.250" upper_limit="0.333"/>
                    <measurement group_id="O6" value="0.250" lower_limit="0.250" upper_limit="0.250"/>
                    <measurement group_id="O7" value="0.250" lower_limit="0.250" upper_limit="0.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>h * ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="85.8" spread="33.9"/>
                    <measurement group_id="O3" value="327" spread="31.2"/>
                    <measurement group_id="O4" value="615" spread="101"/>
                    <measurement group_id="O5" value="1492" spread="140"/>
                    <measurement group_id="O6" value="3025" spread="174"/>
                    <measurement group_id="O7" value="2156" spread="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>h * ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="114" spread="31.9"/>
                    <measurement group_id="O3" value="374" spread="31.8"/>
                    <measurement group_id="O4" value="664" spread="112"/>
                    <measurement group_id="O5" value="1555" spread="147"/>
                    <measurement group_id="O6" value="3087" spread="178"/>
                    <measurement group_id="O7" value="2226" spread="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.45" spread="0.84"/>
                    <measurement group_id="O3" value="2.69" spread="0.50"/>
                    <measurement group_id="O4" value="2.73" spread="0.47"/>
                    <measurement group_id="O5" value="2.50" spread="0.47"/>
                    <measurement group_id="O6" value="1.81" spread="0.32"/>
                    <measurement group_id="O7" value="2.03" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.208" spread="0.041"/>
                    <measurement group_id="O3" value="0.263" spread="0.043"/>
                    <measurement group_id="O4" value="0.259" spread="0.045"/>
                    <measurement group_id="O5" value="0.285" spread="0.054"/>
                    <measurement group_id="O6" value="0.388" spread="0.069"/>
                    <measurement group_id="O7" value="0.347" spread="0.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>mL/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="18,556" spread="4,538"/>
                    <measurement group_id="O3" value="18,328" spread="1,686"/>
                    <measurement group_id="O4" value="16,883" spread="573"/>
                    <measurement group_id="O5" value="18,036" spread="1,558"/>
                    <measurement group_id="O6" value="12,081" spread="535"/>
                    <measurement group_id="O7" value="17,285" spread="1,546"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5,494" spread="1,501"/>
                    <measurement group_id="O3" value="6,934" spread="1,173"/>
                    <measurement group_id="O4" value="6,727" spread="944"/>
                    <measurement group_id="O5" value="7,412" spread="1,473"/>
                    <measurement group_id="O6" value="6,744" spread="911"/>
                    <measurement group_id="O7" value="8,674" spread="1,655"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis</title>
        <description>Single-dose cohorts</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis</title>
          <description>Single-dose cohorts</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="249" spread="59.2"/>
                    <measurement group_id="O3" value="741" spread="50.2"/>
                    <measurement group_id="O4" value="1300" spread="111"/>
                    <measurement group_id="O5" value="3374" spread="490"/>
                    <measurement group_id="O6" value="5715" spread="306"/>
                    <measurement group_id="O7" value="4489" spread="654"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis</title>
        <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis</title>
          <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>h * ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="123" spread="32.0"/>
                    <measurement group_id="O3" value="381" spread="29.6"/>
                    <measurement group_id="O4" value="623" spread="131"/>
                    <measurement group_id="O5" value="1615" spread="142"/>
                    <measurement group_id="O6" value="3195" spread="263"/>
                    <measurement group_id="O7" value="2309" spread="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis</title>
        <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis</title>
          <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.85" spread="0.30"/>
                    <measurement group_id="O3" value="2.69" spread="0.49"/>
                    <measurement group_id="O4" value="3.08" spread="0.65"/>
                    <measurement group_id="O5" value="2.96" spread="0.33"/>
                    <measurement group_id="O6" value="2.40" spread="0.44"/>
                    <measurement group_id="O7" value="2.68" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Half-life (t1/2) of 3K3A-APC by Compartmental Analysis</title>
        <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Half-life (t1/2) of 3K3A-APC by Compartmental Analysis</title>
          <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.246" spread="0.027"/>
                    <measurement group_id="O3" value="0.263" spread="0.043"/>
                    <measurement group_id="O4" value="0.232" spread="0.046"/>
                    <measurement group_id="O5" value="0.237" spread="0.029"/>
                    <measurement group_id="O6" value="0.294" spread="0.054"/>
                    <measurement group_id="O7" value="0.264" spread="0.041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Clearance (CL) of 3K3A-APC by Compartmental Analysis</title>
        <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Total Clearance (CL) of 3K3A-APC by Compartmental Analysis</title>
          <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>mL/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="17,017" spread="4,163"/>
                    <measurement group_id="O3" value="18,016" spread="1,695"/>
                    <measurement group_id="O4" value="17,981" spread="2,321"/>
                    <measurement group_id="O5" value="17,372" spread="1,700"/>
                    <measurement group_id="O6" value="11,693" spread="807"/>
                    <measurement group_id="O7" value="16,665" spread="1,555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis</title>
        <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose</time_frame>
        <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>6 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>30 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>90 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>180 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>360 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O6">
            <title>720 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O7">
            <title>540 µg/kg 3K3A-APC, Single-dose</title>
            <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O8">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis</title>
          <description>Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5967" spread="1236"/>
                    <measurement group_id="O3" value="6831" spread="1231"/>
                    <measurement group_id="O4" value="5931" spread="726"/>
                    <measurement group_id="O5" value="5970" spread="1194"/>
                    <measurement group_id="O6" value="4922" spread="574"/>
                    <measurement group_id="O7" value="6359" spread="1277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis</title>
        <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
        <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis</title>
          <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="810" spread="118"/>
                    <measurement group_id="O2" value="1447" spread="135"/>
                    <measurement group_id="O3" value="2990" spread="608"/>
                    <measurement group_id="O4" value="5577" spread="1134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis</title>
        <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
        <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis</title>
          <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>h * ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="370" spread="145"/>
                    <measurement group_id="O2" value="794" spread="148"/>
                    <measurement group_id="O3" value="1634" spread="365"/>
                    <measurement group_id="O4" value="2750" spread="512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis</title>
        <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
        <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis</title>
          <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.87" spread="1.58"/>
                    <measurement group_id="O2" value="2.50" spread="0.46"/>
                    <measurement group_id="O3" value="2.47" spread="0.20"/>
                    <measurement group_id="O4" value="2.83" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Half-life (t1/2) of 3K3A-APC by Compartmental Analysis</title>
        <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
        <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Half-life (t1/2) of 3K3A-APC by Compartmental Analysis</title>
          <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.211" spread="0.097"/>
                    <measurement group_id="O2" value="0.284" spread="0.044"/>
                    <measurement group_id="O3" value="0.282" spread="0.022"/>
                    <measurement group_id="O4" value="0.247" spread="0.022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Clearance (CL) of 3K3A-APC by Compartmental Analysis</title>
        <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
        <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Total Clearance (CL) of 3K3A-APC by Compartmental Analysis</title>
          <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>mL/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18,701" spread="4,797"/>
                    <measurement group_id="O2" value="17,177" spread="2,593"/>
                    <measurement group_id="O3" value="14,231" spread="2,536"/>
                    <measurement group_id="O4" value="13,647" spread="1,584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis</title>
        <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
        <time_frame>0, 20 minutes and 1 hour post for doses 1 and 5</time_frame>
        <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O2">
            <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O3">
            <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O4">
            <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
            <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
          </group>
          <group group_id="O5">
            <title>Matching Placebo, 0.9% NaCl in Water</title>
            <description>Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes&#xD;
0.9% NaCl in water</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis</title>
          <description>Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.</description>
          <population>All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5151" spread="982"/>
                    <measurement group_id="O2" value="6971" spread="1169"/>
                    <measurement group_id="O3" value="5732" spread="645"/>
                    <measurement group_id="O4" value="4873" spread="828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were reported from the first dose of study drug through 28 Days following the last dose (Day 28 Follow-up visit).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>6 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E2">
          <title>30 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E3">
          <title>90 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E4">
          <title>180 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E5">
          <title>360 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E6">
          <title>720 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E7">
          <title>540 µg/kg 3K3A-APC, Single-dose</title>
          <description>Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E8">
          <title>90 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E9">
          <title>180 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E10">
          <title>360 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E11">
          <title>540 µg/kg 3K3A-APC, q12h for 5 Doses</title>
          <description>Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses&#xD;
3K3A-APC, diluted in 0.9% sodium chloride in water</description>
        </group>
        <group group_id="E12">
          <title>Matching Placebo, 0.9% NaCl in Water</title>
          <description>Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)&#xD;
0.9% NaCl in water</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (12.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="6" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E8" events="12" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E9" events="10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" events="27" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E11" events="17" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="5" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Samples were analyzed from 4 treated subjects in the 6 μg/kg dose group, but all values were below the lower limit of quantitation for the assay (75 ng/mL) and therefore no PK analysis could be performed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kent Pryor, PhD, MBA, Chief Operating Officer</name_or_title>
      <organization>ZZ Biotech, LLC</organization>
      <email>kpryor@zzbiotech.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/NCT01660230
org study id: ZZ-3K3A-001
secondary id: 2011-000793-60
nct id: NCT01660230
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and
      multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.
This is a single-center, sequential-cohort, double-blind, placebo-controlled, single- and
      multiple-ascending dose study. Eligible adult subjects will be assigned sequentially to 1 of
      10 cohorts, at successively higher single doses, followed by successively higher multiple
      doses.

      Single IV Doses: 5 subjects per cohort, aged 18-55, will be randomized in a 4:1 manner to
      receive active drug (6, 30, 90, 180, 360, and TBD µg/kg) or to receive matching placebo
      (Cohorts 1-6).

      Multiple IV Doses: 8 subjects per cohort, aged 18-55, will be randomized in a 3:1 manner to
      receive active drug (90, 180, 360, and TBD µg/kg) or to receive matching placebo every 12
      hours for 5 doses (Cohorts 7-10).

      Single-Dose Cohorts Subjects receiving a single dose will be confined in a Phase 1 unit for
      12 hours prior to dosing, during dosing, and for 24 hours after dosing (Study Day 1-2) for
      observation and PK sampling. Subjects will return on Study Day 4 (~72 hours after infusion)
      and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call will be
      made to subjects to collect AEs that occur within 28-days of the dose.

      Multiple-Dose Cohorts Subjects receiving multiple doses will be confined in a Phase 1 unit
      for 12 hours prior to dosing through 24 hours following the last dose (Study Day 1-4) for
      observation and PK sampling. Subjects will return on Study Day 6 (~72 hours after last
      infusion) and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call
      will be made to subjects to collect AEs that occur within 28-days of the last dose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.
time frame: Day 4 for single-dose cohorts
measure: Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.
time frame: Day 6 for multiple-dose cohorts
measure: Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts
measure: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Half-life (t1/2) of 3K3A-APC by Compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Total Clearance (CL) of 3K3A-APC by Compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis
time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
description: Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis
time frame: 0, 20 minutes and 1 hour post for doses 1 and 5
description: Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis
time frame: 0, 20 minutes and 1 hour post for doses 1 and 5
description: Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis
time frame: 0, 20 minutes and 1 hour post for doses 1 and 5
description: Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Half-life (t1/2) of 3K3A-APC by Compartmental Analysis
time frame: 0, 20 minutes and 1 hour post for doses 1 and 5
description: Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Total Clearance (CL) of 3K3A-APC by Compartmental Analysis
time frame: 0, 20 minutes and 1 hour post for doses 1 and 5
description: Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
measure: Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis
time frame: 0, 20 minutes and 1 hour post for doses 1 and 5
description: Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
arm group label: 6 µg/kg 3K3A-APC, single-dose
arm group type: Active Comparator
description: Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
arm group label: 30 µg/kg 3K3A-APC, single-dose
arm group type: Active Comparator
description: Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
arm group label: 90 µg/kg 3K3A-APC, single-dose
arm group type: Active Comparator
description: Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
arm group label: 180 µg/kg 3K3A-APC, single-dose
arm group type: Active Comparator
description: Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
arm group label: 360 µg/kg 3K3A-APC, single-dose
arm group type: Active Comparator
description: Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
arm group label: TBD µg/kg 3K3A-APC, single-dose
arm group type: Active Comparator
description: Cohort 6: TBD (not to exceed 720) µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
arm group label: 90 µg/kg 3K3A-APC, q12h for 5 doses
arm group type: Active Comparator
description: Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
arm group label: 180 µg/kg 3K3A-APC, q12h for 5 doses
arm group type: Active Comparator
description: Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
arm group label: 360 µg/kg 3K3A-APC, q12h for 5 doses
arm group type: Active Comparator
description: Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
arm group label: TBD µg/kg 3K3A-APC, q12h for 5 doses
arm group type: Active Comparator
description: Cohort 10: TBD (not to exceed 720) µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
arm group label: Matching Placebo, 0.9% NaCl in water
arm group type: Placebo Comparator
description: Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
intervention type: Biological
intervention name: 3K3A-APC, diluted in 0.9% sodium chloride in water
arm group label: 180 µg/kg 3K3A-APC, q12h for 5 doses
arm group label: 180 µg/kg 3K3A-APC, single-dose
arm group label: 30 µg/kg 3K3A-APC, single-dose
arm group label: 360 µg/kg 3K3A-APC, q12h for 5 doses
arm group label: 360 µg/kg 3K3A-APC, single-dose
arm group label: 6 µg/kg 3K3A-APC, single-dose
arm group label: 90 µg/kg 3K3A-APC, q12h for 5 doses
arm group label: 90 µg/kg 3K3A-APC, single-dose
arm group label: TBD µg/kg 3K3A-APC, q12h for 5 doses
arm group label: TBD µg/kg 3K3A-APC, single-dose
intervention type: Drug
intervention name: 0.9% NaCl in water
arm group label: Matching Placebo, 0.9% NaCl in water
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick D Lyden, MD, FAAN
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Howard Levy, MD, PhD, MMM
role: Study Director
affiliation: ZZ Biotech, LLC
facility: 
country: Austria
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Samples were analyzed from 4 treated subjects in the 6 μg/kg dose group, but all values were below the lower limit of quantitation for the assay (75 ng/mL) and therefore no PK analysis could be performed.
point of contact: 