xml: <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/NCT06037395</url>
    </required_header>
    <id_info>
      <org_study_id>CT-P41 1.2</org_study_id>
      <nct_id>NCT06037395</nct_id>
    </id_info>
    <brief_title>Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects</brief_title>
    <official_title>A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Celltrion</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Celltrion</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare&#xD;
        the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in&#xD;
        Healthy Male Subjects&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I&#xD;
        study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed&#xD;
        Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a&#xD;
        single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for&#xD;
        253 days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 6, 2021</start_date>
    <completion_date type="Actual">October 20, 2022</completion_date>
    <primary_completion_date type="Actual">October 20, 2022</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>
      <intervention_model_description>Two-arm, Parallel group</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>A Randomized, Double-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>AUCinf</measure>
      <time_frame>up to Day 253</time_frame>
      <description>Area under the concentration-time curve from time zero to infinity (AUC0-inf)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AUClast</measure>
      <time_frame>up to Day 253</time_frame>
      <description>Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax</measure>
      <time_frame>up to Day 253</time_frame>
      <description>maximum serum concentration (Cmax)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">154</enrollment>
    <condition>Healthy Subject</condition>
    <arm_group>
      <arm_group_label>CT-P41</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>US-licensed Prolia</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>CT-P41</intervention_name>
      <description>a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)</description>
      <arm_group_label>CT-P41</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>US-licensed Prolia</intervention_name>
      <description>a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)</description>
      <arm_group_label>US-licensed Prolia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy male subject, between the ages of 28 and 55 years, both inclusive&#xD;
  &#xD;
            2. Subject had a body mass index (BMI) between 18.5 and 29.9 kg/m2, both inclusive, and a&#xD;
               body weight between 50.0 and 99.9 kg, both inclusive, when rounded to the nearest&#xD;
               tenth.&#xD;
  &#xD;
            3. Subject with total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) and serum 25-OH vitamin&#xD;
               D ≥ 20 ng/mL (≥ 50 nmol/L)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject was a female.&#xD;
  &#xD;
            2. Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a&#xD;
               derivative of latex).&#xD;
  &#xD;
            3. Subject was confirmed or suspected with infection of coronavirus disease 2019&#xD;
               (COVID-19) at screening, or had had contact with COVID-19 patient within 14 days from&#xD;
               screening.&#xD;
  &#xD;
            4. Subject had a medical history of and/or current medical condition that can have effect&#xD;
               on the study. Details to be discussed with investigator as per Protocol.&#xD;
  &#xD;
                 1. Subjects with known risk factors for hypocalcaemia&#xD;
  &#xD;
                 2. Subjects with known intolerance to calcium or vitamin D supplements&#xD;
  &#xD;
                 3. Subjects with known infection with active hepatitis B, hepatitis C, human&#xD;
                    immunodeficiency virus, or syphilis&#xD;
  &#xD;
            5. Subject had a history of and/or concurrent use of medications including any prior&#xD;
               therapy that can have effect on the study. Details to be discussed with investigator&#xD;
               as per Protocol.&#xD;
  &#xD;
            6. Subjects have or had any therapy that might significantly affect bone metabolism&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>28 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CHA Bundang Medical Center</name>
        <address>
          <city>Seongnam</city>
          <state>Bundang-gu</state>
          <zip>13520</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Chungnam National University Hospital</name>
        <address>
          <city>Daejeon</city>
          <state>Jung-gu</state>
          <zip>35015</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>CT-P41</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Denosumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037395
  org study id: CT-P41 1.2
  nct id: NCT06037395
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare
        the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in
        Healthy Male Subjects
  This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I
        study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed
        Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a
        single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for
        253 days.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two-arm, Parallel group
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: A Randomized, Double-blind
  measure: AUCinf
  time frame: up to Day 253
  description: Area under the concentration-time curve from time zero to infinity (AUC0-inf)
  measure: AUClast
  time frame: up to Day 253
  description: Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
  measure: Cmax
  time frame: up to Day 253
  description: maximum serum concentration (Cmax)
  arm group label: CT-P41
  arm group type: Experimental
  description: a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
  arm group label: US-licensed Prolia
  arm group type: Active Comparator
  description: a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
  intervention type: Biological
  intervention name: CT-P41
  description: a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
  arm group label: CT-P41
  intervention type: Biological
  intervention name: US-licensed Prolia
  description: a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
  arm group label: US-licensed Prolia
  criteria: 
  gender: Male
  minimum age: 28 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Denosumab
  sharing ipd: No