<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/NCT02979015</url>
  </required_header>
  <id_info>
    <org_study_id>PKD13404</org_study_id>
    <secondary_id>U1111-1133-7871</secondary_id>
    <nct_id>NCT02979015</nct_id>
  </id_info>
  <brief_title>A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Alirocumab in Chinese Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese&#xD;
      healthy subjects.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess the pharmacokinetic profile of a single SC dose of alirocumab.&#xD;
&#xD;
        -  To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density&#xD;
           lipoprotein cholesterol (LDL-C) and other lipid parameters.&#xD;
&#xD;
        -  To assess the immunogenicity of a single SC dose of alirocumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post&#xD;
      dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding&#xD;
      with a next dose. Total duration of the study per subject is approximately 15 weeks&#xD;
      (including screening period).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 29, 2016</start_date>
  <completion_date type="Actual">November 27, 2017</completion_date>
  <primary_completion_date type="Actual">November 27, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of injection site reactions</measure>
    <time_frame>Up to 4 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in LDL-C</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in other lipid parameters</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Assessment of serum concentrations of alirocumab</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Assessment of serum concentrations of PCSK9</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subcutaneous injection of a single dose of matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alirocumab SAR236553 (REGN727)</intervention_name>
    <description>Pharmaceutical form: Solution for injection&#xD;
Route of administration: Subcutaneous</description>
    <arm_group_label>Alirocumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Pharmaceutical form: Solution for injection&#xD;
Route of administration: Subcutaneous</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Healthy male or female subjects.&#xD;
&#xD;
          -  Aged 18 to 45 years old.&#xD;
&#xD;
          -  Low-density lipoprotein cholesterol &gt;100 mg/dL (2.59 mmol/L).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Subjects with any history or presence of clinically relevant illness.&#xD;
&#xD;
          -  Serum triglycerides &gt;200 mg/dL (2.26 mmol/L) measured after at least 10 hour fasting.&#xD;
&#xD;
          -  Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks&#xD;
             prior to screening, including but not limited to statins, ezetimibe, fibrates, niacin,&#xD;
             or bile acid resins. Use of probucol within 8 weeks prior to screening.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 156001</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</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>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alirocumab</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/NCT02979015
org study id: PKD13404
secondary id: U1111-1133-7871
nct id: NCT02979015
lead sponsor: 
collaborator: 
has dmc: No
Primary Objective:

      To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese
      healthy subjects.

      Secondary Objectives:

        -  To assess the pharmacokinetic profile of a single SC dose of alirocumab.

        -  To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density
           lipoprotein cholesterol (LDL-C) and other lipid parameters.

        -  To assess the immunogenicity of a single SC dose of alirocumab.
Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post
      dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding
      with a next dose. Total duration of the study per subject is approximately 15 weeks
      (including screening period).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests
time frame: Up to 12 weeks
measure: Incidence of injection site reactions
time frame: Up to 4 days
measure: Change from baseline in LDL-C
time frame: Up to 12 weeks
measure: Change from baseline in other lipid parameters
time frame: Up to 12 weeks
measure: Pharmacokinetics: Assessment of serum concentrations of alirocumab
time frame: Up to 12 weeks
measure: Pharmacokinetics: Assessment of serum concentrations of PCSK9
time frame: Up to 12 weeks
arm group label: Alirocumab
arm group type: Experimental
description: Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design
arm group label: Placebo
arm group type: Placebo Comparator
description: Subcutaneous injection of a single dose of matching placebo
intervention type: Drug
intervention name: alirocumab SAR236553 (REGN727)
description: Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
arm group label: Alirocumab
intervention type: Drug
intervention name: placebo
description: Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
country: China
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Alirocumab