<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/NCT03273842</url>
  </required_header>
  <id_info>
    <org_study_id>C1221005</org_study_id>
    <secondary_id>IMM HSP-130</secondary_id>
    <nct_id>NCT03273842</nct_id>
  </id_info>
  <brief_title>A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers</brief_title>
  <official_title>Phase 1, Randomized Open Label, Multiple Dose, Parallel Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of The Proposed Pegfilgrastim Biosimilar (PF-06881894) And Us-approved Neulasta (Registered) In Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the immune response to the proposed biosimilar PF-06881894 and the&#xD;
      US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6&#xD;
      milligrams [mg]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1&#xD;
      of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose&#xD;
      assessments of immunogenicity will be conducted each of the two treatment periods. In&#xD;
      addition, safety assessments will be conducted throughout the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Actual">July 25, 2018</completion_date>
  <primary_completion_date type="Actual">July 25, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and confirmed postdose positive anti-pegfilgrastim antibody test result at any time during the study.</measure>
    <time_frame>90 days (through Period 1 Day1 to Period 2 Day 60 or final visit)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and postdose positive neutralizing antibody result at any time during the study.</measure>
    <time_frame>90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">422</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>PF-06881894</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PF-06881894 6 mg SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US-approved Neulasta</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>US-approved Neulasta 6 mg SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06881894</intervention_name>
    <description>pre-filled syringe 6 mg</description>
    <arm_group_label>PF-06881894</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>US-approved Neulasta</intervention_name>
    <description>pre-filled syringe 6 mg</description>
    <arm_group_label>US-approved Neulasta</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Healthy males or females between 18 and 65 years of age (both inclusive) with body mass&#xD;
        index between 19 and 30 kg/m2, inclusive, and body weight of not &lt;50 kg or &gt;95 kg, will be&#xD;
        enrolled in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hematologic laboratory abnormalities (including leukocytosis [defined as total&#xD;
             leukocytes &gt;11,000/mcL], leukopenia [defined as total leukocytes &lt;4000/mcL], or&#xD;
             neutropenia [defined as absolute neutrophil count &lt;1500/mcL] or thrombocytopenia&#xD;
             [defined as platelet count of &lt;150,000/mcL]) or other clinically significant abnormal&#xD;
             laboratory evaluations.&#xD;
&#xD;
          -  Lack of adequate hepatic or renal reserve.&#xD;
&#xD;
          -  Any active systemic or immunologic disease or condition.&#xD;
&#xD;
          -  History of biological growth factor exposure.&#xD;
&#xD;
          -  Received live vaccination or exposure to communicable viral diseases within 4 weeks&#xD;
             prior to Screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seaview A Quotient Clinical Business</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quotient Sciences- Jacksonville, LLC</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seaview A Quotient Clinical Business</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vince &amp; Associates Clinical Research Inc.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C1221005&amp;StudyName=Phase+1%2C+Randomized+Open+Label%2C+Multiple+Dose%2C+Parallel+Study+To+Assess+The+Immunogenicity+Of+Multiple+Subcutaneous+%28sc%29+Doses+Of+The+Proposed+Pegfilgrastim+Biosimilar+%28pf-06881894%29+And+Us-approved+Neulasta+%28registered%29+In+Healthy+Volunteers</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests</ipd_description>
  </patient_data>
  <!-- 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/NCT03273842
org study id: C1221005
secondary id: IMM HSP-130
nct id: NCT03273842
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study compares the immune response to the proposed biosimilar PF-06881894 and the
      US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6
      milligrams [mg]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1
      of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose
      assessments of immunogenicity will be conducted each of the two treatment periods. In
      addition, safety assessments will be conducted throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and confirmed postdose positive anti-pegfilgrastim antibody test result at any time during the study.
time frame: 90 days (through Period 1 Day1 to Period 2 Day 60 or final visit)
measure: The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and postdose positive neutralizing antibody result at any time during the study.
time frame: 90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit)
arm group label: PF-06881894
arm group type: Experimental
description: PF-06881894 6 mg SC
arm group label: US-approved Neulasta
arm group type: Active Comparator
description: US-approved Neulasta 6 mg SC
intervention type: Biological
intervention name: PF-06881894
description: pre-filled syringe 6 mg
arm group label: PF-06881894
intervention type: Biological
intervention name: US-approved Neulasta
description: pre-filled syringe 6 mg
arm group label: US-approved Neulasta
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C1221005&StudyName=Phase+1%2C+Randomized+Open+Label%2C+Multiple+Dose%2C+Parallel+Study+To+Assess+The+Immunogenicity+Of+Multiple+Subcutaneous+%28sc%29+Doses+Of+The+Proposed+Pegfilgrastim+Biosimilar+%28pf-06881894%29+And+Us-approved+Neulasta+%28registered%29+In+Healthy+Volunteers
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
sharing ipd: No
ipd description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests