<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/NCT04494373</url>
  </required_header>
  <id_info>
    <org_study_id>HS-20090-101</org_study_id>
    <nct_id>NCT04494373</nct_id>
  </id_info>
  <brief_title>Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults</brief_title>
  <official_title>A Randomized, Double-blinded and Parallel Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Hansoh Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Hansoh Pharmaceutical Co., Ltd.</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>
      A randomized, double-blind and parallel group study to compare the pharmacokinetic,&#xD;
      pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I, single center, randomized, double-blind and parallel group clinical trial&#xD;
      .&#xD;
&#xD;
      The primary objective is to assess the pharmacokinetic similarity of single subcutaneously&#xD;
      injection of HS-20090 or Xgeva® in healthy volunteers.&#xD;
&#xD;
      The secondary objectives are to assess the Clinical safety and immunogenicity similarity of&#xD;
      single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers.&#xD;
      Meanwhile，observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC0-t )</measure>
    <time_frame>155days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>155days</time_frame>
    <description>maximum concentration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events(AE)</measure>
    <time_frame>155days</time_frame>
    <description>The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum type 1 C-telopeptide(CTX1)</measure>
    <time_frame>155days</time_frame>
    <description>explore the pharmacodynamic profile by detecting the serum concentration of CTX1</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Antidrug antibody(ADA):</measure>
    <time_frame>155days</time_frame>
    <description>percentage of subjects positive for antidrug antibody</description>
  </other_outcome>
  <other_outcome>
    <measure>Neutralizing antibody(Nab)</measure>
    <time_frame>155days</time_frame>
    <description>percentage of subjects positive for Nab</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">154</enrollment>
  <condition>Bone Metastasis From Solid Tumors</condition>
  <arm_group>
    <arm_group_label>HS-20090</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xgeva®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HS-20090</intervention_name>
    <description>A human IgG2 monoclonal antibody with affinity and specificity for human RANKL</description>
    <arm_group_label>HS-20090</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xgeva®</intervention_name>
    <description>A human IgG2 monoclonal antibody with affinity and specificity for human RANKL</description>
    <arm_group_label>Xgeva®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sign the informed consent form and fully understand the test content, process and&#xD;
             possible adverse reactions, and be able to complete the study according to the test&#xD;
             plan requirements;&#xD;
&#xD;
          -  Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value);&#xD;
&#xD;
          -  Agree to take effective contraceptive measures throughout the study period until at&#xD;
             least 6 months after the last drug is administered;&#xD;
&#xD;
          -  Clinical laboratory examination, chest X-ray, abdominal B-ultrasound,&#xD;
             electrocardiogram, physical examination, vital signs and various examinations are&#xD;
             normal or abnormal without clinical significance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously; The&#xD;
             dental or jaw disease that is active, requiring oral surgery; or planned for invasive&#xD;
             dental surgery during the study; or dental or oral surgery wounds have not healed;&#xD;
&#xD;
          -  Serum calcium levels are outside the normal range of the laboratory.&#xD;
&#xD;
          -  Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C&#xD;
             antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive&#xD;
             HIV antibodies, or positive test for syphilis.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             product within the following time period prior to the first dosing day in the current&#xD;
             study: 3 months or 5 half-lives (whichever is longer).&#xD;
&#xD;
          -  Prior use of medications within 6 months before and during the study. This includes&#xD;
             medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium&#xD;
             Parathyroid hormone or derivatives Supplemental vitamin D (&gt;1000 IU/day)&#xD;
             Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to&#xD;
             enrolment are allowed) Anabolic steroids Calcitriol Diuretics&#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>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_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/NCT04494373
org study id: HS-20090-101
nct id: NCT04494373
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A randomized, double-blind and parallel group study to compare the pharmacokinetic,
      pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy
      adults.
This is a phase I, single center, randomized, double-blind and parallel group clinical trial
      .

      The primary objective is to assess the pharmacokinetic similarity of single subcutaneously
      injection of HS-20090 or Xgeva® in healthy volunteers.

      The secondary objectives are to assess the Clinical safety and immunogenicity similarity of
      single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers.
      Meanwhile，observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Area under the plasma concentration-time curve (AUC0-t )
time frame: 155days
measure: Cmax
time frame: 155days
description: maximum concentration
measure: Adverse events(AE)
time frame: 155days
description: The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
measure: Serum type 1 C-telopeptide(CTX1)
time frame: 155days
description: explore the pharmacodynamic profile by detecting the serum concentration of CTX1
measure: Antidrug antibody(ADA):
time frame: 155days
description: percentage of subjects positive for antidrug antibody
measure: Neutralizing antibody(Nab)
time frame: 155days
description: percentage of subjects positive for Nab
arm group label: HS-20090
arm group type: Experimental
description: Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day
arm group label: Xgeva®
arm group type: Active Comparator
description: Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day
intervention type: Drug
intervention name: HS-20090
description: A human IgG2 monoclonal antibody with affinity and specificity for human RANKL
arm group label: HS-20090
intervention type: Drug
intervention name: Xgeva®
description: A human IgG2 monoclonal antibody with affinity and specificity for human RANKL
arm group label: Xgeva®
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Neoplasm Metastasis