<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/NCT04428814</url>
  </required_header>
  <id_info>
    <org_study_id>CT-P43 1.1</org_study_id>
    <nct_id>NCT04428814</nct_id>
  </id_info>
  <brief_title>Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects</brief_title>
  <official_title>A Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study&#xD;
      to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection&#xD;
      Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy&#xD;
      Male Subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab). This study will&#xD;
      be conducted in 2 parts. In Part 1, subjects will be enrolled and randomized in a 1:1 ratio&#xD;
      to receive a single dose (45 mg) of either CT-P43 or EU-approved Stelara to collect&#xD;
      preliminary safety data for CT-P43. In Part 2, subjects will be enrolled and randomized in a&#xD;
      1:1:1 ratio to receive a single dose (45 mg) of CT-P43, EU-approved Stelara, or US-licensed&#xD;
      Stelara to demonstrate PK similarity. Each part will proceed independently, and subjects will&#xD;
      be randomized to either Part 1 or Part 2 of the study subsequently. All subjects in Part 1&#xD;
      and Part 2 will undergo the same assessments. In each treatment arm in Part 1 and Part 2, all&#xD;
      subjects will receive a study drug subcutaneously via PFS. The randomization to treatment&#xD;
      assignment will be stratified by study center and body weight as measured at baseline to&#xD;
      balance subject weight across treatment groups. Subjects will be confined to the study center&#xD;
      until all required 24-hour post-dose assessments have been completed and will be discharged&#xD;
      on Day 2. Subsequent visits will be carried out on an out-patient basis up to EOS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">February 24, 2021</completion_date>
  <primary_completion_date type="Actual">February 24, 2021</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstrate PK similarity</measure>
    <time_frame>through study completion, up to day 127</time_frame>
    <description>under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43, EU-approved Stelara, and US-licensed Stelara</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Demonstrate PK similarity</measure>
    <time_frame>through study completion, up to day 127</time_frame>
    <description>maximum serum concentration (Cmax) of CT-P43, EU-approved Stelara, and US-licensed Stelara</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">271</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>CT-P43 (Part 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>45mg single dose administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EU-approved Stelara (Part 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>45mg single dose administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CT-P43 (Part 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>45mg single dose administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EU-approved Stelara (Part 2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>45mg single dose administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US-licensed Stelara (Part 2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>45mg single dose administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CT-P43</intervention_name>
    <description>45mg single dose</description>
    <arm_group_label>CT-P43 (Part 1)</arm_group_label>
    <arm_group_label>CT-P43 (Part 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EU-approved Stelara</intervention_name>
    <description>45mg single dose</description>
    <arm_group_label>EU-approved Stelara (Part 1)</arm_group_label>
    <arm_group_label>EU-approved Stelara (Part 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>US-licensed Stelara</intervention_name>
    <description>45mg single dose</description>
    <arm_group_label>US-licensed Stelara (Part 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male subjects, between the ages of 18 and 55 years.&#xD;
&#xD;
          2. Subject with a BMI between 18.5 and 29.9 kg/m2. Weight between 60 to 100 kg.&#xD;
&#xD;
          3. Subject must agree to use medically acceptable methods of contraception consistent&#xD;
             with local regulations during the course of the study and for 18 weeks after&#xD;
             administration of the study drug.&#xD;
&#xD;
          4. Subject is informed and able to understand the full nature and purpose of the study,&#xD;
             including possible risks and side effects, and is given ample time and opportunity to&#xD;
             read and understand this information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a prohibited medical history and/or current condition.&#xD;
&#xD;
          2. Subject is planning to father a child or donate sperm within 18 weeks after the&#xD;
             administration of the study drug (Day 1).&#xD;
&#xD;
          3. Subject previously received any biologic agents&#xD;
&#xD;
          4. In the opinion of the investigator, the subject is not eligible for the study&#xD;
             participation for any reason.&#xD;
&#xD;
          5. Subject is vulnerable.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Auckland Clinical Studies Limited</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Clinical Studies Trust Limited</name>
      <address>
        <city>Christchurch</city>
        <state>Canterbury</state>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ustekinumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04428814
org study id: CT-P43 1.1
nct id: NCT04428814
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study
      to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection
      Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy
      Male Subjects.
CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab). This study will
      be conducted in 2 parts. In Part 1, subjects will be enrolled and randomized in a 1:1 ratio
      to receive a single dose (45 mg) of either CT-P43 or EU-approved Stelara to collect
      preliminary safety data for CT-P43. In Part 2, subjects will be enrolled and randomized in a
      1:1:1 ratio to receive a single dose (45 mg) of CT-P43, EU-approved Stelara, or US-licensed
      Stelara to demonstrate PK similarity. Each part will proceed independently, and subjects will
      be randomized to either Part 1 or Part 2 of the study subsequently. All subjects in Part 1
      and Part 2 will undergo the same assessments. In each treatment arm in Part 1 and Part 2, all
      subjects will receive a study drug subcutaneously via PFS. The randomization to treatment
      assignment will be stratified by study center and body weight as measured at baseline to
      balance subject weight across treatment groups. Subjects will be confined to the study center
      until all required 24-hour post-dose assessments have been completed and will be discharged
      on Day 2. Subsequent visits will be carried out on an out-patient basis up to EOS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Demonstrate PK similarity
time frame: through study completion, up to day 127
description: under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43, EU-approved Stelara, and US-licensed Stelara
measure: Demonstrate PK similarity
time frame: through study completion, up to day 127
description: maximum serum concentration (Cmax) of CT-P43, EU-approved Stelara, and US-licensed Stelara
arm group label: CT-P43 (Part 1)
arm group type: Experimental
description: 45mg single dose administration
arm group label: EU-approved Stelara (Part 1)
arm group type: Active Comparator
description: 45mg single dose administration
arm group label: CT-P43 (Part 2)
arm group type: Experimental
description: 45mg single dose administration
arm group label: EU-approved Stelara (Part 2)
arm group type: Active Comparator
description: 45mg single dose administration
arm group label: US-licensed Stelara (Part 2)
arm group type: Active Comparator
description: 45mg single dose administration
intervention type: Biological
intervention name: CT-P43
description: 45mg single dose
arm group label: CT-P43 (Part 1)
arm group label: CT-P43 (Part 2)
intervention type: Biological
intervention name: EU-approved Stelara
description: 45mg single dose
arm group label: EU-approved Stelara (Part 1)
arm group label: EU-approved Stelara (Part 2)
intervention type: Biological
intervention name: US-licensed Stelara
description: 45mg single dose
arm group label: US-licensed Stelara (Part 2)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Ustekinumab