Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1033 (SAR391786)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01720576
First received: October 29, 2012
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

This is a study to assess the safety and tolerability of subcutaneously administered REGN1033 (SAR391786) in healthy volunteers.


Condition Intervention Phase
Healthy Volunteers
Drug: REGN1033 (SAR391786)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Number of TEAEs [ Time Frame: Day 1 to Day 141 ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Serum concentration of REGN1033 (SAR391786) [ Time Frame: Day 1 to Day 141 ] [ Designated as safety issue: No ]
    Serum concentration of REGN1033 (SAR391786) over time

  • immunogenicity [ Time Frame: Day 1 to Day 141 ] [ Designated as safety issue: No ]
    Presence or absence of anti-REGN1033 (SAR391786) antibodies over time (immunogenicity )


Enrollment: 60
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose 1 of REGN1033 (SAR391786) or Placebo
Drug: REGN1033 (SAR391786) Drug: Placebo
Experimental: Cohort 2
Dose 2 of REGN1033 (SAR391786) or Placebo
Drug: REGN1033 (SAR391786) Drug: Placebo
Experimental: Cohort 3
Dose 3 of REGN1033 (SAR391786) or Placebo
Drug: REGN1033 (SAR391786) Drug: Placebo

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Eligible subjects are males and females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.

A subject must meet the following criteria to be eligible for inclusion in the study:

  1. Sexually active males willing to use contraceptives during the study and through 4 months after the study.
  2. Female subjects not of child bearing potential (surgically sterile or postmenopausal for longer than 1 year)
  3. Body mass index (BMI) between 18.5 and 32 kg/m2 inclusive
  4. Willing to maintain current diet and exercise routine for the duration of the study
  5. Willing and able to return for all clinic visits and complete all study-related procedures
  6. Able to read and understand, and willing to sign the ICF

Exclusion Criteria:

  1. Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
  2. Evidence of malnutrition
  3. Cachexia of any cause
  4. Evidence or history of muscle diseases or weakness with the exception of age related muscle loss
  5. Limb amputation
  6. Immobilization, surgical procedure, fracture, or trauma to the upper or lower limb within 6 months
  7. History or evidence of heart diseases including but not limited to coronary heart disease with/without history of myocardial infarction, chronic or acute heart failure (New York Heart Association [NYHA] stage 2-4), cardiac arrhythmia with clinical symptoms, valvular heart disease, and cardiac hypertrophy of clinical significance
  8. Women of childbearing potential (not surgically sterile or amenorrheic for at least 12 months if postmenopausal)
  9. Uncontrolled diabetes defined as HbA1C > 7.5 at screening; if taking oral hypoglycemic drugs, have to be on stable doses of medication for more than 3 months. Diabetics using insulin are excluded
  10. Asthmatic subjects with current or recurring symptoms within 1 year.
  11. History of, COPD, chronic kidney disease, cancer except primary basal-cell skin cancer that has been adequately treated
  12. Neurological injury (eg, stroke) within 1 year
  13. Abnormal or uncontrolled blood pressure at screening visit defined as diastolic BP >95 and/or systolic BP >160 mm Hg; if taking hypertensive medication, have to be on stable doses of medication for more than 3 months
  14. Hepatic transaminases (ALT and or AST) > 2X ULN
  15. Reduced renal function as defined by eGFR<60 mL/min
  16. Current smokers or previous smokers who stopped smoking within 6 months
  17. Current or recent history (within 1 year of screen) of alcohol or drug abuse
  18. History of hypersensitivity response to any biologics
  19. History of hypersensitivity to doxycycline or other tetracycline antibiotics
  20. Current or recent participation in any clinical trial (within 30 days of small molecular drugs or within 3 months of biologics)
  21. Exposure within 3 months to approved biological drugs. (The name of the drug and duration of previous exposure will be recorded). Vaccines are allowed.
  22. Sexually active men* who are unwilling to practice adequate contraception during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720576

Locations
United States, Florida
Daytona Beach, Florida, United States
United States, Indiana
Evansville, Indiana, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01720576     History of Changes
Other Study ID Numbers: R1033-HV-1204
Study First Received: October 29, 2012
Last Updated: September 10, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 31, 2014