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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01507402
First received: January 6, 2012
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) 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: Parallel Assignment
Masking: Double Blind (Subject, 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 113 ] [ Designated as safety issue: Yes ]
    The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in subjects treated with REGN1033 or placebo, reported from the time of administration of study drug on day 1 (baseline) to completion of the study (day 113).


Secondary Outcome Measures:
  • Serum concentration [ Time Frame: Baseline to End of Study (Day 113) ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetic (PK) profile (i.e. serum concentration) of IV and SC doses of REGN1033.

  • Immunogenicity [ Time Frame: Baseline to End of Study (Day 113) ] [ Designated as safety issue: No ]
    To assess the potential for immunogenicity following IV and SC doses of REGN1033.


Enrollment: 76
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose regimen 1 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: Placebo
(inactive substance)
Experimental: Cohort 2
Dose regimen 2 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: Placebo
(inactive substance)
Experimental: Cohort 3
Dose regimen 3 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: Placebo
(inactive substance)
Experimental: Cohort 4
Dose regimen 4 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: Placebo
(inactive substance)
Experimental: Cohort 5
Dose regimen 5 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
Experimental: Cohort 6
Dose regimen 6 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
Experimental: Cohort 7
Dose regimen 7 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
Experimental: Cohort 8
Dose regimen 3 (Participants > 65 to ≤ 85 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: Placebo
(inactive substance)
Experimental: Cohort 9
Dose regimen 9 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: Placebo
(inactive substance)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males and postmenopausal or surgically sterile females
  2. Body mass index (BMI) between 18 and 30 kg/m2 inclusive
  3. Willing and able to return for all clinic visits and complete all study-related procedures
  4. Able to read and understand, and willing to sign the ICF

Exclusion Criteria:

  1. Significant concomitant illness or history of significant illness such as, but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
  2. History of muscle neoplasms such as rhabdomyoma, rhabdomyosarcoma, leiomyoma, leiomyosarcoma or uterine fibroid tumors
  3. History of muscular dystrophy, myositis, and other primary diseases of skeletal muscle
  4. History of heart diseases including but not limited to coronary heart disease with/without history of myocardial infarction, chronic or acute heart failure, or cardiac arrhythmia, valvular heart disease or cardiac hypertrophy. Subjects taking prophylactic aspirin are excluded from the study and should not discontinue taking prophylactic aspirin to participate in the study
  5. History of systemic hypertension or use of concomitant medications to treat hypertension, or history of pulmonary hypertension
  6. History of diabetes mellitus or gestational diabetes or use of concomitant medications for treatment of these
  7. Recent use of androgenic steroids
  8. Unexplained creatine phosphokinase (CPK) levels >3X upper limit of normal.
  9. Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
  10. Women of childbearing potential (not surgically sterile or amenorrheic for at least twelve months if postmenopausal)
  11. Onset of a new exercise routine or major change to a previous exercise or diet routine within 4 weeks prior to screening. Subjects must be willing to maintain his/her previous level of exercise for the duration of the study
  12. Known history of seropositivity to human immunodeficiency virus (HIV) antibody; hepatitis B surface antigen or hepatitis C antibody (HCV) associated with a positive HCV RNA polymerase chain reaction at the screening visit
  13. Positive urine drug test results during screening or history of drug or alcohol abuse within a year prior to the screening visit
  14. Any hospitalization within 60 days prior to the screening visit
  15. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
  16. History of a hypersensitivity reaction to doxycycline or to other tetracycline drugs
  17. Previous exposure to any biological therapeutic agent, excepting vaccines
  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: NCT01507402

Locations
United States, Hawaii
Honolulu, Hawaii, United States
United States, Indiana
Evansville, Indiana, United States, 47710
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: NCT01507402     History of Changes
Other Study ID Numbers: R1033-HV-1107
Study First Received: January 6, 2012
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 20, 2014