<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/NCT04411550</url>
  </required_header>
  <id_info>
    <org_study_id>HLX11-001</org_study_id>
    <nct_id>NCT04411550</nct_id>
  </id_info>
  <brief_title>Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects</brief_title>
  <official_title>A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Henlius Biotech</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Henlius Biotech</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed&#xD;
      to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male&#xD;
      subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>from predose to 2352 hours (Day 99),13 timepoints</time_frame>
    <description>Peak concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0~t</measure>
    <time_frame>from predose to 2352 hours (Day 99),13 timepoints</time_frame>
    <description>Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0~inf</measure>
    <time_frame>from predose to 2352 hours (Day 99),13 timepoints</time_frame>
    <description>Area under the plasma concentration-time curve from time 0 to infinity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>safety and tolerability of 4 groups</measure>
    <time_frame>from day1 to day 99</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety and tolerability of 4 groups</measure>
    <time_frame>from day1 to day 99</time_frame>
    <description>Number of AE as assessed by CTCAE v5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety and tolerability of two groups</measure>
    <time_frame>from day1 to day 99</time_frame>
    <description>AE listing as assessed by CTCAE v5.0</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Healthy Male Volunteers</condition>
  <arm_group>
    <arm_group_label>HLX11 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CN-Perjeta group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EU-Perjeta group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US-Perjeta group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HLX11</intervention_name>
    <description>healthy volunteers receive HLX11 (420mg) once</description>
    <arm_group_label>HLX11 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CN-Perjeta(Pertuzumab)</intervention_name>
    <description>healthy volunteers receive CN-Perjeta (420mg) once</description>
    <arm_group_label>CN-Perjeta group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EU-Perjeta(Pertuzumab)</intervention_name>
    <description>healthy volunteers receive EU-Perjeta (420mg) once</description>
    <arm_group_label>EU-Perjeta group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>US-Perjeta(Pertuzumab)</intervention_name>
    <description>healthy volunteers receive US-Perjeta (420mg) once</description>
    <arm_group_label>US-Perjeta group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Chinese males&#xD;
&#xD;
          -  aged ≥ 18 and ≤ 45&#xD;
&#xD;
          -  body mass index (BMI) ≥ 19 and ≤ 26 kg/m2&#xD;
&#xD;
          -  LVEF≥ 55%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of any serious clinical disease such as haematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases,&#xD;
             and tumour, or allergic diseases&#xD;
&#xD;
          -  Use of a monoclonal antibody or any biological product within 6 months before study&#xD;
             drug administration&#xD;
&#xD;
          -  A history of allergic reactions or anaphylaxis, including such reactions to any drug&#xD;
             or excipient in the clinical study&#xD;
&#xD;
          -  Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese&#xD;
             medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements)&#xD;
             within 28 days before study drug administration&#xD;
&#xD;
          -  A history of blood donation within 3 months before study drug administration&#xD;
&#xD;
          -  Participation in other clinical study and use of the investigational&#xD;
             product/comparator within 3 months before study drug administration&#xD;
&#xD;
          -  Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody,&#xD;
             human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody&#xD;
&#xD;
          -  A history of drug abuse&#xD;
&#xD;
          -  Failure to comply with protocol requirements, instructions, and study limitations,&#xD;
             such as uncooperative attitude, failure to return to the study site for follow-up&#xD;
             visits, or failure to complete the entire clinical study, as judged by investigators&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Hu</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Hospital of Anhui Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hui Zhao</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Hospital of Anhui Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available. Erratum In: Clin Pharmacol Ther. 2022 Apr 17;:1344.</citation>
    <PMID>35132630</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</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>Pertuzumab</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/NCT04411550
org study id: HLX11-001
nct id: NCT04411550
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed
      to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male
      subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Cmax
time frame: from predose to 2352 hours (Day 99),13 timepoints
description: Peak concentration
measure: AUC0~t
time frame: from predose to 2352 hours (Day 99),13 timepoints
description: Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point
measure: AUC0~inf
time frame: from predose to 2352 hours (Day 99),13 timepoints
description: Area under the plasma concentration-time curve from time 0 to infinity
measure: safety and tolerability of 4 groups
time frame: from day1 to day 99
description: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
measure: safety and tolerability of 4 groups
time frame: from day1 to day 99
description: Number of AE as assessed by CTCAE v5.0
measure: safety and tolerability of two groups
time frame: from day1 to day 99
description: AE listing as assessed by CTCAE v5.0
arm group label: HLX11 group
arm group type: Experimental
description: HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
arm group label: CN-Perjeta group
arm group type: Active Comparator
description: CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
arm group label: EU-Perjeta group
arm group type: Active Comparator
description: EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
arm group label: US-Perjeta group
arm group type: Active Comparator
description: US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
intervention type: Drug
intervention name: HLX11
description: healthy volunteers receive HLX11 (420mg) once
arm group label: HLX11 group
intervention type: Drug
intervention name: CN-Perjeta(Pertuzumab)
description: healthy volunteers receive CN-Perjeta (420mg) once
arm group label: CN-Perjeta group
intervention type: Drug
intervention name: EU-Perjeta(Pertuzumab)
description: healthy volunteers receive EU-Perjeta (420mg) once
arm group label: EU-Perjeta group
intervention type: Drug
intervention name: US-Perjeta(Pertuzumab)
description: healthy volunteers receive US-Perjeta (420mg) once
arm group label: US-Perjeta group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wei Hu
role: Principal Investigator
affiliation: The Second Hospital of Anhui Medical University
last name: Hui Zhao
role: Principal Investigator
affiliation: The Second Hospital of Anhui Medical University
facility: 
country: China
citation: American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available. Erratum In: Clin Pharmacol Ther. 2022 Apr 17;:1344.
PMID: 35132630
responsible party type: Sponsor
mesh term: Pertuzumab
sharing ipd: No