<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/NCT03242239</url>
  </required_header>
  <id_info>
    <org_study_id>ALT02</org_study_id>
    <nct_id>NCT03242239</nct_id>
  </id_info>
  <brief_title>A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects</brief_title>
  <official_title>A Randomized, Double-Blind, Parallel, Phase I Pharmacokinetic Trial Comparing The Potential Biosimilar ALT02(Trastuzumab) With Herceptin in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alteogen, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cristália Produtos Químicos Farmacêuticos Ltda.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Alteogen, Inc.</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>
      The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin®&#xD;
      (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the&#xD;
      pharmacokinetics, safety, tolerability and immunogenicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2016</start_date>
  <completion_date type="Actual">September 30, 2016</completion_date>
  <primary_completion_date type="Actual">August 4, 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-inf: area under the concentration-time curve from time zero to infinity</measure>
    <time_frame>43 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-t: area under the concentration-time curve from time zero to the last non-zero concentration</measure>
    <time_frame>43 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax: maximum observed concentration</measure>
    <time_frame>43 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax: time of observed Cmax</measure>
    <time_frame>43 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kel: apparent terminal elimination rate constant</measure>
    <time_frame>43 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T½ el: apparent terminal half-life</measure>
    <time_frame>43 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL: apparent body clearance, calculated as Dose/AUC0-inf</measure>
    <time_frame>43 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd: apparent volume of distribution, calculated as Dose/(kel x AUC0-inf)</measure>
    <time_frame>43 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>ALT02</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>EU-licensed Herceptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>US-licensed Herceptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALT02</intervention_name>
    <arm_group_label>ALT02</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EU-licensed Herceptin</intervention_name>
    <arm_group_label>EU-licensed Herceptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>US-licensed Herceptin</intervention_name>
    <arm_group_label>US-licensed Herceptin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects&#xD;
&#xD;
          -  Have a body weight over 50.0 kg and a body mass index over than 18.5 and less than&#xD;
             30.0 kg/m², inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically significant abnormality or abnormal laboratory test results found&#xD;
             during medical screening or positive test for hepatitis B, hepatitis C, or HIV found&#xD;
             during medical screening.&#xD;
&#xD;
          -  Positive urine drug screen or alcohol breath test at screening.&#xD;
&#xD;
          -  History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or&#xD;
             other related drugs.&#xD;
&#xD;
          -  Any reason which, in the opinion of the Qualified Investigator, would prevent the&#xD;
             subject from participating in the study.&#xD;
&#xD;
          -  Clinically significant electrocardiogram (ECG) abnormalities or vital sign&#xD;
             abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood&#xD;
             pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at&#xD;
             screening.&#xD;
&#xD;
          -  History of significant alcohol abuse within one year prior to screening or regular use&#xD;
             of alcohol within six months prior to the screening visit (more than fourteen units of&#xD;
             alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).&#xD;
&#xD;
          -  History of significant drug abuse within one year prior to screening or use of soft&#xD;
             drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs&#xD;
             (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.&#xD;
&#xD;
          -  Use of trastuzumab or another monoclonal antibody for a medical condition or in the&#xD;
             context of another clinical trial.&#xD;
&#xD;
          -  Participation in a clinical research study involving the administration of an&#xD;
             investigational or marketed drug or device within 30 days prior to dosing,&#xD;
             administration of a biological product in the context of a clinical research study&#xD;
             within 90 days prior to dosing, or concomitant participation in an investigational&#xD;
             study involving no drug or device administration.&#xD;
&#xD;
          -  Use of medication other than topical products without significant systemic absorption:&#xD;
&#xD;
               1. prescription medication within 14 days prior to dose administration;&#xD;
&#xD;
               2. over-the-counter products including natural health products (e.g. food&#xD;
                  supplements and herbal supplements) within 7 days prior to dosing, with the&#xD;
                  exception of the occasional use of acetaminophen (up to 2 g daily);&#xD;
&#xD;
               3. a depot injection or an implant of any drug within 3 months prior to dose&#xD;
                  administration.&#xD;
&#xD;
          -  Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding&#xD;
             volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than&#xD;
             499 mL within 56 days prior to dosing.&#xD;
&#xD;
          -  Hemoglobin &lt;128 g/L and hematocrit &lt;0.37 L/L at screening.&#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>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HER2 Positive Breast Cancer</keyword>
  <keyword>Trastuzumab</keyword>
  <keyword>Biosimilar</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</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/NCT03242239
org study id: ALT02
nct id: NCT03242239
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin®
      (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the
      pharmacokinetics, safety, tolerability and immunogenicity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: AUC0-inf: area under the concentration-time curve from time zero to infinity
time frame: 43 days
measure: AUC0-t: area under the concentration-time curve from time zero to the last non-zero concentration
time frame: 43 days
measure: Cmax: maximum observed concentration
time frame: 43 days
measure: Tmax: time of observed Cmax
time frame: 43 days
measure: Kel: apparent terminal elimination rate constant
time frame: 43 days
measure: T½ el: apparent terminal half-life
time frame: 43 days
measure: CL: apparent body clearance, calculated as Dose/AUC0-inf
time frame: 43 days
measure: Vd: apparent volume of distribution, calculated as Dose/(kel x AUC0-inf)
time frame: 43 days
arm group label: ALT02
arm group type: Experimental
arm group label: EU-licensed Herceptin
arm group type: Active Comparator
arm group label: US-licensed Herceptin
arm group type: Active Comparator
intervention type: Biological
intervention name: ALT02
arm group label: ALT02
intervention type: Biological
intervention name: EU-licensed Herceptin
arm group label: EU-licensed Herceptin
intervention type: Biological
intervention name: US-licensed Herceptin
arm group label: US-licensed Herceptin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Trastuzumab