<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/NCT03251248</url>
  </required_header>
  <id_info>
    <org_study_id>EMR200621-001</org_study_id>
    <nct_id>NCT03251248</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects</brief_title>
  <official_title>A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Bioequivalence of a Single Injection of MSB11455 and Neulasta in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Kabi SwissBioSim GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fresenius Kabi SwissBioSim GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of&#xD;
      MSB11455 and Neulasta in healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">October 17, 2018</completion_date>
  <primary_completion_date type="Actual">May 8, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-Time Curve From Time Zero (Pre-dose) Extrapolated to Infinity AUC(0-inf) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Effect-Time Curve From Time Zero (Pre-dose) to Last Measured Time (AUE0-t) for (ANC) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant (λz) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Half-life (t1/2) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under Effect Curve from zero to 360 hours (AUEC0-360) for ANC of MSB11455 and Neulasta</measure>
    <time_frame>Pre-dose up to 15 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)</measure>
    <time_frame>Day 1 up to a maximum of 15 months</time_frame>
    <description>Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">294</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>First MSB11455 Then Neulasta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>First Neulasta Then MSB11455</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MSB11455</intervention_name>
    <description>Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.</description>
    <arm_group_label>First MSB11455 Then Neulasta</arm_group_label>
    <arm_group_label>First Neulasta Then MSB11455</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neulasta</intervention_name>
    <description>Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.</description>
    <arm_group_label>First MSB11455 Then Neulasta</arm_group_label>
    <arm_group_label>First Neulasta Then MSB11455</arm_group_label>
    <other_name>pegfilgrastim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who provide signed and dated written informed consent&#xD;
&#xD;
          -  Other protocol defined inclusion criteria could apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have no known hypersensitivity to any component of Neulasta or MSB11455,&#xD;
             and laboratory test results within predefined ranges&#xD;
&#xD;
          -  Other protocol defined exclusion criteria could apply.&#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>Radmila Kanceva, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Fresenius Kabi SwissBioSim GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nucleus Network</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q-Pharm Pty Ltd</name>
      <address>
        <city>Herston</city>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>June 28, 2019</last_update_submitted>
  <last_update_submitted_qc>June 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MSB11455</keyword>
  <keyword>Healthy subjects</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03251248
org study id: EMR200621-001
nct id: NCT03251248
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of
      MSB11455 and Neulasta in healthy adult subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Area Under the Concentration-Time Curve From Time Zero (Pre-dose) Extrapolated to Infinity AUC(0-inf) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Area Under the Effect-Time Curve From Time Zero (Pre-dose) to Last Measured Time (AUE0-t) for (ANC) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Terminal rate constant (λz) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Terminal Half-life (t1/2) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Area Under Effect Curve from zero to 360 hours (AUEC0-360) for ANC of MSB11455 and Neulasta
time frame: Pre-dose up to 15 days post-dose
measure: Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)
time frame: Day 1 up to a maximum of 15 months
description: Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs
arm group label: First MSB11455 Then Neulasta
arm group type: Experimental
arm group label: First Neulasta Then MSB11455
arm group type: Experimental
intervention type: Drug
intervention name: MSB11455
description: Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.
arm group label: First MSB11455 Then Neulasta
arm group label: First Neulasta Then MSB11455
intervention type: Drug
intervention name: Neulasta
description: Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.
arm group label: First MSB11455 Then Neulasta
arm group label: First Neulasta Then MSB11455
other name: pegfilgrastim
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Radmila Kanceva, MD, PhD
role: Study Director
affiliation: Fresenius Kabi SwissBioSim GmbH
facility: 
facility: 
country: Australia
responsible party type: Sponsor