<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/NCT03776240</url>
  </required_header>
  <id_info>
    <org_study_id>TROIKA-1</org_study_id>
    <nct_id>NCT03776240</nct_id>
  </id_info>
  <brief_title>A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects</brief_title>
  <acronym>TROIKA-1</acronym>
  <official_title>A Phase I, Double-Blind, Randomised, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prestige Biopharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prestige Biopharma Limited</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of&#xD;
      HD201 to the European (EU) and American (US) reference products Herceptin, following a single&#xD;
      i.v. infusion of 6 mg/kg in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind, randomised, parallel group study, where a total of 105 healthy adult&#xD;
      male volunteers, ≥ 18 and ≤ 55 years of age, non-smoker, will be dosed; 35 subjects per&#xD;
      treatment group, randomly assigned to one of the 3 treatment arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">August 19, 2019</completion_date>
  <primary_completion_date type="Actual">August 19, 2019</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>Screening</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under Curve (AUC, Pharmacokinetics)</measure>
    <time_frame>Up to day 54</time_frame>
    <description>Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity: Incidence of anti-herceptin antibodies</measure>
    <time_frame>0 hour, Day 15, Day 29, Day 43, and Day 54 post-dose</time_frame>
    <description>Incidence of anti-herceptin antibodies</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>HD201</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EU-licensed Herceptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US-licensed Herceptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HD201</intervention_name>
    <description>Single-dose 6mg/kg body weight by 90 minute intravenous infusion</description>
    <arm_group_label>HD201</arm_group_label>
    <other_name>Trastuzumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EU-Herceptin</intervention_name>
    <description>Single-dose 6mg/kg body weight by 90 minute intravenous infusion</description>
    <arm_group_label>EU-licensed Herceptin</arm_group_label>
    <other_name>Trastuzumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>US-Herceptin</intervention_name>
    <description>Single-dose 6mg/kg body weight by 90 minute intravenous infusion</description>
    <arm_group_label>US-licensed Herceptin</arm_group_label>
    <other_name>Trastuzumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male, non-smoker (no use of tobacco products within 3 months prior to screening), ≥ 18&#xD;
             and ≤ 55 years of age, with BMI &gt; 18.5 and &lt; 30.0 kg/m2 and body weight ≥ 50.0 kg.&#xD;
&#xD;
          2. Healthy as defined by:&#xD;
&#xD;
               1. the absence of clinically significant illness and surgery within 4 weeks prior to&#xD;
                  dosing. Inclusion pre-dosing is at the discretion of the Principal Investigator.&#xD;
&#xD;
               2. the absence of clinically significant history of neurological, endocrinal,&#xD;
                  cardiovascular, pulmonary, hematological, immunologic, psychiatric,&#xD;
                  gastrointestinal, renal, hepatic, and metabolic disease.&#xD;
&#xD;
               3. a LVEF within the normal range as measured by echocardiogram (ECHO) within 4&#xD;
                  weeks prior to randomization.&#xD;
&#xD;
               4. the absence of clinically significant history of anaphylaxis, angioedema,&#xD;
                  interstitial pneumonitis, or acute respiratory distress syndrome.&#xD;
&#xD;
          3. Male subjects who are not vasectomized for at least 6 months, and who are sexually&#xD;
             active with non-sterile female partner [sterile female partners include&#xD;
             post-menopausal women (absence of menses for 12 months prior to drug administration)&#xD;
             or women who have had a tubal ligation, hysterectomy, or bilateral oophorectomy (at&#xD;
             least 6 months prior to drug administration)] must be willing to use one of the&#xD;
             following acceptable contraceptive method throughout the study and for 90 days after&#xD;
             the last study drug administration:&#xD;
&#xD;
               1. simultaneous use of condom, and for the female partner hormonal contraceptives&#xD;
                  (used since at least 4 weeks) or intra-uterine contraceptive device (placed since&#xD;
                  at least 4 weeks);&#xD;
&#xD;
               2. simultaneous use of male condom, and for the female partner, diaphragm with&#xD;
                  intravaginally applied spermicide.&#xD;
&#xD;
          4. Male subjects, including men who have had vasectomy, with a pregnant partner must&#xD;
             agree to use a condom throughout the study and for 90 days after the last study drug&#xD;
             administration.&#xD;
&#xD;
          5. Male subjects must be willing not to donate sperm until 90 days following the last&#xD;
             study drug administration.&#xD;
&#xD;
          6. Capable of consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        f the following applies will be excluded from the study:&#xD;
&#xD;
          1. 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;
          2. Positive urine drug screen at screening.&#xD;
&#xD;
          3. History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or&#xD;
             other related drugs.&#xD;
&#xD;
          4. Any reason which, in the opinion of the Principal Investigator, would prevent the&#xD;
             subject from participating in the study.&#xD;
&#xD;
          5. Clinically significant ECG abnormalities (QTc &gt;450 ms) and or vital sign abnormalities&#xD;
             (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure&#xD;
             lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at&#xD;
             screening.&#xD;
&#xD;
          6. 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;
          7. 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], crack, opioid derivatives including heroin, and&#xD;
             amphetamine derivatives) within 1 year prior to screening.&#xD;
&#xD;
          8. Previous use of trastuzumab or another monoclonal antibody for a medical condition or&#xD;
             in the context of another clinical trial.&#xD;
&#xD;
          9. Participation in a clinical research study involving the administration of an&#xD;
             investigational or marketed drug or device within 30 days prior to the first dosing,&#xD;
             administration of a biological product in the context of a clinical research study&#xD;
             within 90 days prior to the first dosing, or concomitant participation in an&#xD;
             investigational study involving no drug or device administration.&#xD;
&#xD;
         10. 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 (paracetamol - 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;
         11. 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 the first dosing.&#xD;
&#xD;
         12. Hemoglobin &lt; 12.8 g/dL 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>
  <overall_official>
    <last_name>Litha Jaison</last_name>
    <role>Study Chair</role>
    <affiliation>Prestige Biopharma Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Q Pharm</name>
      <address>
        <city>Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>randomized</keyword>
  <keyword>double-blind</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03776240
org study id: TROIKA-1
nct id: NCT03776240
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of
      HD201 to the European (EU) and American (US) reference products Herceptin, following a single
      i.v. infusion of 6 mg/kg in healthy volunteers.
This is a double-blind, randomised, parallel group study, where a total of 105 healthy adult
      male volunteers, ≥ 18 and ≤ 55 years of age, non-smoker, will be dosed; 35 subjects per
      treatment group, randomly assigned to one of the 3 treatment arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Triple (Participant, Care Provider, Investigator)
measure: Area under Curve (AUC, Pharmacokinetics)
time frame: Up to day 54
description: Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin
measure: Immunogenicity: Incidence of anti-herceptin antibodies
time frame: 0 hour, Day 15, Day 29, Day 43, and Day 54 post-dose
description: Incidence of anti-herceptin antibodies
arm group label: HD201
arm group type: Experimental
description: Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
arm group label: EU-licensed Herceptin
arm group type: Active Comparator
description: Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
arm group label: US-licensed Herceptin
arm group type: Active Comparator
description: Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
intervention type: Drug
intervention name: HD201
description: Single-dose 6mg/kg body weight by 90 minute intravenous infusion
arm group label: HD201
other name: Trastuzumab
intervention type: Drug
intervention name: EU-Herceptin
description: Single-dose 6mg/kg body weight by 90 minute intravenous infusion
arm group label: EU-licensed Herceptin
other name: Trastuzumab
intervention type: Drug
intervention name: US-Herceptin
description: Single-dose 6mg/kg body weight by 90 minute intravenous infusion
arm group label: US-licensed Herceptin
other name: Trastuzumab
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Litha Jaison
role: Study Chair
affiliation: Prestige Biopharma Limited
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Trastuzumab
sharing ipd: Undecided