<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/NCT03030430</url>
  </required_header>
  <id_info>
    <org_study_id>BAT-1706-001</org_study_id>
    <nct_id>NCT03030430</nct_id>
  </id_info>
  <brief_title>Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects</brief_title>
  <official_title>Randomized, Double-blind, Single-dose, 3-arm Parallel Design Comparative Pharmacokinetic(PK) and Safety Study of BAT1706 Versus European Union(EU)-Sourced Avastin® and United State (US)-Sourced Avastin® Administered in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bio-Thera Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bio-Thera Solutions</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish PK similarity in the treatment of BAT1706 and&#xD;
      comparators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to&#xD;
      compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706,&#xD;
      EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects.&#xD;
&#xD;
      A total of 129 healthy male subjects who meet the required entry criteria will be randomly&#xD;
      assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of&#xD;
      either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required.&#xD;
&#xD;
      Initially, subjects will be administered the study drug in staggered groups; the first group&#xD;
      will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within&#xD;
      each group subjects will be randomized to ensure equal numbers of subjects receive each of&#xD;
      the three treatments.&#xD;
&#xD;
      There will be at least 48 hours between administrations of study drug to each group. Prior to&#xD;
      administration of study drug to the next group, the safety and tolerability findings of the&#xD;
      preceding group will be reviewed by the Principal Investigator. The next group will be dosed&#xD;
      provided there are no serious or unexpected drug-related safety issues. Each subject will be&#xD;
      required to remain in the clinical center for 48 hours after dosing for safety evaluation.&#xD;
&#xD;
      After the first 3 groups have been evaluated, the Principal Investigator will decide whether&#xD;
      to proceed with continuous enrolment according to the clinical center capability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2016</start_date>
  <completion_date type="Actual">June 28, 2017</completion_date>
  <primary_completion_date type="Actual">May 16, 2017</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>area under curve (AUC)0~∞</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>NSCLC</condition>
  <arm_group>
    <arm_group_label>BAT1706</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BAT1706 injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EU-sourced Avastin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EU-sourced Avastin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US-sourced Avastin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>US-sourced Avastin</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BAT1706 injection</intervention_name>
    <description>1mg/kg, IV on day 1</description>
    <arm_group_label>BAT1706</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EU-sourced Avastin</intervention_name>
    <description>1mg/kg, IV on day 1</description>
    <arm_group_label>EU-sourced Avastin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>US-sourced Avastin</intervention_name>
    <description>1mg/kg, IV on day 1</description>
    <arm_group_label>US-sourced Avastin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult males aged 18 to 50 years inclusive and body weight 65 to 100kg.&#xD;
&#xD;
          2. Subjects who are healthy as determined by pre-study medical history, physical&#xD;
             examination, vital signs and 12 ECG.&#xD;
&#xD;
          3. Subjects whose clinical laboratory test results are normal, or where outside the&#xD;
             reference range are judged as not clinical relevant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a history of and/or current clinically significant gastrointestinal, renal,&#xD;
             hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric&#xD;
             or allergic disease excluding mild asymptomatic seasonal allergies.&#xD;
&#xD;
          2. Subject with a psychiatric disorder or considered unsuitable for inclusion by the&#xD;
             investigator.&#xD;
&#xD;
          3. History or current clinically significant, excluding mild asymptomatic seasonal&#xD;
             allergies, hypersensitivity or allergic reactions including known or suspected drug&#xD;
             hypersensitivity to any component of the study drug formulations or comparable drugs.&#xD;
&#xD;
          4. Any biological drug within 3 months or monoclonal antibodies within 9 months of study&#xD;
             drug administration.&#xD;
&#xD;
          5. Intake of herbal remedies within 14 days prior to study drug administration.&#xD;
&#xD;
          6. History of alcohol abuse or a positive alcohol test on screening or admission to the&#xD;
             clinical center.&#xD;
&#xD;
          7. Any persons who are:an employee of the Principal Investigator, clinical center,&#xD;
             Clinical Research Organization (CRO) or Sponsor;a relative of an employee of the&#xD;
             clinical center, the Investigators, CRO or the Sponsor.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Wynne, Medical Doc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christchurch Clinical Studies Trust Ltd (CCST)</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</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>Bevacizumab</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>November 5, 2020</submitted>
    <returned>December 3, 2020</returned>
  </pending_results>
  <!-- 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/NCT03030430
org study id: BAT-1706-001
nct id: NCT03030430
lead sponsor: 
The purpose of this study is to establish PK similarity in the treatment of BAT1706 and
      comparators.
This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to
      compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706,
      EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects.

      A total of 129 healthy male subjects who meet the required entry criteria will be randomly
      assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of
      either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required.

      Initially, subjects will be administered the study drug in staggered groups; the first group
      will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within
      each group subjects will be randomized to ensure equal numbers of subjects receive each of
      the three treatments.

      There will be at least 48 hours between administrations of study drug to each group. Prior to
      administration of study drug to the next group, the safety and tolerability findings of the
      preceding group will be reviewed by the Principal Investigator. The next group will be dosed
      provided there are no serious or unexpected drug-related safety issues. Each subject will be
      required to remain in the clinical center for 48 hours after dosing for safety evaluation.

      After the first 3 groups have been evaluated, the Principal Investigator will decide whether
      to proceed with continuous enrolment according to the clinical center capability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: area under curve (AUC)0~∞
time frame: 4 months
arm group label: BAT1706
arm group type: Experimental
description: BAT1706 injection
arm group label: EU-sourced Avastin
arm group type: Active Comparator
description: EU-sourced Avastin
arm group label: US-sourced Avastin
arm group type: Active Comparator
description: US-sourced Avastin
intervention type: Biological
intervention name: BAT1706 injection
description: 1mg/kg, IV on day 1
arm group label: BAT1706
intervention type: Biological
intervention name: EU-sourced Avastin
description: 1mg/kg, IV on day 1
arm group label: EU-sourced Avastin
intervention type: Biological
intervention name: US-sourced Avastin
description: 1mg/kg, IV on day 1
arm group label: US-sourced Avastin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chris Wynne, Medical Doc
role: Principal Investigator
affiliation: Director
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Bevacizumab
submitted: November 5, 2020
returned: December 3, 2020