<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/NCT03013881</url>
  </required_header>
  <id_info>
    <org_study_id>UBP-A103-HER2</org_study_id>
    <nct_id>NCT03013881</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers</brief_title>
  <official_title>Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United BioPharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>United BioPharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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 evaluate the safety, tolerability, and pharmacokinetics of&#xD;
      escalating single-dose of UB-921 in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of&#xD;
      UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main&#xD;
      Study) and comparative pharmacokinetics study (Sub-study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2018</start_date>
  <completion_date type="Actual">April 2, 2019</completion_date>
  <primary_completion_date type="Actual">October 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>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse event incidence</measure>
    <time_frame>63 days</time_frame>
    <description>from the baseline to the end of study visit</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>UB-921 2 mg/kg (Main-study)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-921 6 mg/kg (Main-study)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-921 8 mg/kg (Main-study)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-921 6 mg/kg (Sub-study)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Herceptin 6 mg/kg (Sub-study)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UB-921</intervention_name>
    <description>150 mg/vial</description>
    <arm_group_label>UB-921 2 mg/kg (Main-study)</arm_group_label>
    <arm_group_label>UB-921 6 mg/kg (Main-study)</arm_group_label>
    <arm_group_label>UB-921 6 mg/kg (Sub-study)</arm_group_label>
    <arm_group_label>UB-921 8 mg/kg (Main-study)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Herceptin</intervention_name>
    <description>440 mg/vial</description>
    <arm_group_label>Herceptin 6 mg/kg (Sub-study)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total body weight ≧50 kg (110 lbs)&#xD;
&#xD;
          -  No clinically relevant abnormalities&#xD;
&#xD;
          -  To agree on using birth control barrier (eg. male condom) during the entire study&#xD;
             period.&#xD;
&#xD;
          -  Signing the written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous exposure to chimeric, humanized or human monoclonal antibody, whether&#xD;
             licensed or investigational&#xD;
&#xD;
          -  A history of drug abuse or heavy drinking.&#xD;
&#xD;
          -  Blood donation over 250 mL within 90 days prior to the screening&#xD;
&#xD;
          -  Not in the condition to participate in this study considered by investigator(s)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsiang-Cheng Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tri-Service General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prime site</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>UB-921</keyword>
  <keyword>anti-HER2 monoclonal antibody</keyword>
  <keyword>breast neoplasm</keyword>
  <keyword>breast cancer</keyword>
  <keyword>Herceptin</keyword>
  <keyword>Trastuzumab</keyword>
  <keyword>HER2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03013881
org study id: UBP-A103-HER2
nct id: NCT03013881
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of
      escalating single-dose of UB-921 in healthy male volunteers.
This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of
      UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main
      Study) and comparative pharmacokinetics study (Sub-study).
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse event incidence
time frame: 63 days
description: from the baseline to the end of study visit
arm group label: UB-921 2 mg/kg (Main-study)
arm group type: Experimental
description: Intravenous infusion
arm group label: UB-921 6 mg/kg (Main-study)
arm group type: Experimental
description: Intravenous infusion
arm group label: UB-921 8 mg/kg (Main-study)
arm group type: Experimental
description: Intravenous infusion
arm group label: UB-921 6 mg/kg (Sub-study)
arm group type: Experimental
description: Intravenous infusion
arm group label: Herceptin 6 mg/kg (Sub-study)
arm group type: Active Comparator
description: Intravenous infusion
intervention type: Biological
intervention name: UB-921
description: 150 mg/vial
arm group label: UB-921 2 mg/kg (Main-study)
arm group label: UB-921 6 mg/kg (Main-study)
arm group label: UB-921 6 mg/kg (Sub-study)
arm group label: UB-921 8 mg/kg (Main-study)
intervention type: Biological
intervention name: Herceptin
description: 440 mg/vial
arm group label: Herceptin 6 mg/kg (Sub-study)
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hsiang-Cheng Chen
role: Principal Investigator
affiliation: Tri-Service General Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Trastuzumab
sharing ipd: No