<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/NCT03251339</url>
  </required_header>
  <id_info>
    <org_study_id>EMR200621-003</org_study_id>
    <nct_id>NCT03251339</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of MSB11455 in Healthy Participants</brief_title>
  <official_title>A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety 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 primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and&#xD;
      Neulasta in healthy adult participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">September 22, 2018</completion_date>
  <primary_completion_date type="Actual">February 5, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To Assess the Immunogenicity of MSB11455 Compared to Neulasta</measure>
    <time_frame>From first dose up to end of study (Up to 3 months)</time_frame>
    <description>Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB)</description>
  </primary_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 1 year</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">336</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>MSB11455</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US-Neulasta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MSB11455</intervention_name>
    <description>Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.</description>
    <arm_group_label>MSB11455</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>US-Neulasta</intervention_name>
    <description>Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.</description>
    <arm_group_label>US-Neulasta</arm_group_label>
    <other_name>pegfilgrastim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who provide signed and dated written informed consent.&#xD;
&#xD;
          -  Participants with laboratory test results within predefined ranges.&#xD;
&#xD;
          -  Other protocol defined inclusion criteria could apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with known hypersensitivity to any component of US-Neulasta or MSB11455.&#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</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Auckland Clinical Studies Ltd</name>
      <address>
        <city>Auckland</city>
        <zip>1150</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Clinical Studies Trust</name>
      <address>
        <city>Christchurch</city>
        <zip>8001</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 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>Healthy Participants</keyword>
  <keyword>MSB11455</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/NCT03251339
org study id: EMR200621-003
nct id: NCT03251339
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and
      Neulasta in healthy adult participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: To Assess the Immunogenicity of MSB11455 Compared to Neulasta
time frame: From first dose up to end of study (Up to 3 months)
description: Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB)
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 1 year
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: MSB11455
arm group type: Experimental
description: Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.
arm group label: US-Neulasta
arm group type: Experimental
description: Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.
intervention type: Drug
intervention name: MSB11455
description: Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.
arm group label: MSB11455
intervention type: Drug
intervention name: US-Neulasta
description: Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.
arm group label: US-Neulasta
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
facility: 
facility: 
country: New Zealand
country: Germany
responsible party type: Sponsor