<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/NCT01720576</url>
  </required_header>
  <id_info>
    <org_study_id>R1033-HV-1204</org_study_id>
    <nct_id>NCT01720576</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1033 (SAR391786)</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to assess the safety and tolerability of subcutaneously administered REGN1033&#xD;
      (SAR391786) in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of TEAEs</measure>
    <time_frame>Day 1 to Day 141</time_frame>
    <description>The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in participants treated with REGN1033 (SAR391786) or placebo, reported from the time of administration of study drug on day 1 (baseline) to day 141 (end of study).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum concentration of REGN1033 (SAR391786)</measure>
    <time_frame>Day 1 to Day 141</time_frame>
    <description>Serum concentration of REGN1033 (SAR391786) over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>immunogenicity</measure>
    <time_frame>Day 1 to Day 141</time_frame>
    <description>Presence or absence of anti-REGN1033 (SAR391786) antibodies over time (immunogenicity )</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose 1 of REGN1033 (SAR391786) or Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose 2 of REGN1033 (SAR391786) or Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose 3 of REGN1033 (SAR391786) or Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>REGN1033 (SAR391786)</intervention_name>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible subjects are males and females aged 60 years and older with no significant health&#xD;
        issues or clinically significant abnormal laboratory values.&#xD;
&#xD;
        A subject must meet the following criteria to be eligible for inclusion in the study:&#xD;
&#xD;
          1. Sexually active males willing to use contraceptives during the study and through 4&#xD;
             months after the study.&#xD;
&#xD;
          2. Female subjects not of child bearing potential (surgically sterile or postmenopausal&#xD;
             for longer than 1 year)&#xD;
&#xD;
          3. Body mass index (BMI) between 18.5 and 32 kg/m2 inclusive&#xD;
&#xD;
          4. Willing to maintain current diet and exercise routine for the duration of the study&#xD;
&#xD;
          5. Willing and able to return for all clinic visits and complete all study-related&#xD;
             procedures&#xD;
&#xD;
          6. Able to read and understand, and willing to sign the ICF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant concomitant illness such as, but not limited to cardiac, renal,&#xD;
             rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic,&#xD;
             psychiatric, endocrine, metabolic or immunological disease.&#xD;
&#xD;
          2. Evidence of malnutrition&#xD;
&#xD;
          3. Cachexia of any cause&#xD;
&#xD;
          4. Evidence or history of muscle diseases or weakness with the exception of age related&#xD;
             muscle loss&#xD;
&#xD;
          5. Limb amputation&#xD;
&#xD;
          6. Immobilization, surgical procedure, fracture, or trauma to the upper or lower limb&#xD;
             within 6 months&#xD;
&#xD;
          7. History or evidence of heart diseases including but not limited to coronary heart&#xD;
             disease with/without history of myocardial infarction, chronic or acute heart failure&#xD;
             (New York Heart Association [NYHA] stage 2-4), cardiac arrhythmia with clinical&#xD;
             symptoms, valvular heart disease, and cardiac hypertrophy of clinical significance&#xD;
&#xD;
          8. Women of childbearing potential (not surgically sterile or amenorrheic for at least 12&#xD;
             months if postmenopausal)&#xD;
&#xD;
          9. Uncontrolled diabetes defined as HbA1C &gt; 7.5 at screening; if taking oral hypoglycemic&#xD;
             drugs, have to be on stable doses of medication for more than 3 months. Diabetics&#xD;
             using insulin are excluded&#xD;
&#xD;
         10. Asthmatic subjects with current or recurring symptoms within 1 year.&#xD;
&#xD;
         11. History of, COPD, chronic kidney disease, cancer except primary basal-cell skin cancer&#xD;
             that has been adequately treated&#xD;
&#xD;
         12. Neurological injury (eg, stroke) within 1 year&#xD;
&#xD;
         13. Abnormal or uncontrolled blood pressure at screening visit defined as diastolic BP &gt;95&#xD;
             and/or systolic BP &gt;160 mm Hg; if taking hypertensive medication, have to be on stable&#xD;
             doses of medication for more than 3 months&#xD;
&#xD;
         14. Hepatic transaminases (ALT and or AST) &gt; 2X ULN&#xD;
&#xD;
         15. Reduced renal function as defined by eGFR&lt;60 mL/min&#xD;
&#xD;
         16. Current smokers or previous smokers who stopped smoking within 6 months&#xD;
&#xD;
         17. Current or recent history (within 1 year of screen) of alcohol or drug abuse&#xD;
&#xD;
         18. History of hypersensitivity response to any biologics&#xD;
&#xD;
         19. History of hypersensitivity to doxycycline or other tetracycline antibiotics&#xD;
&#xD;
         20. Current or recent participation in any clinical trial (within 30 days of small&#xD;
             molecular drugs or within 3 months of biologics)&#xD;
&#xD;
         21. Exposure within 3 months to approved biological drugs. (The name of the drug and&#xD;
             duration of previous exposure will be recorded). Vaccines are allowed.&#xD;
&#xD;
         22. Sexually active men* who are unwilling to practice adequate contraception during the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>September 10, 2013</last_update_submitted>
  <last_update_submitted_qc>September 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01720576
org study id: R1033-HV-1204
nct id: NCT01720576
lead sponsor: 
collaborator: 
has dmc: No
This is a study to assess the safety and tolerability of subcutaneously administered REGN1033
      (SAR391786) in healthy volunteers.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of TEAEs
time frame: Day 1 to Day 141
description: The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in participants treated with REGN1033 (SAR391786) or placebo, reported from the time of administration of study drug on day 1 (baseline) to day 141 (end of study).
measure: Serum concentration of REGN1033 (SAR391786)
time frame: Day 1 to Day 141
description: Serum concentration of REGN1033 (SAR391786) over time
measure: immunogenicity
time frame: Day 1 to Day 141
description: Presence or absence of anti-REGN1033 (SAR391786) antibodies over time (immunogenicity )
arm group label: Cohort 1
arm group type: Experimental
description: Dose 1 of REGN1033 (SAR391786) or Placebo
arm group label: Cohort 2
arm group type: Experimental
description: Dose 2 of REGN1033 (SAR391786) or Placebo
arm group label: Cohort 3
arm group type: Experimental
description: Dose 3 of REGN1033 (SAR391786) or Placebo
intervention type: Drug
intervention name: REGN1033 (SAR391786)
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
intervention type: Drug
intervention name: Placebo
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
country: United States
responsible party type: Sponsor