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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: REGN1033(SAR391786); Drug: REGN1033(SAR391786); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States
  • Indiana
    • Evansville, Indiana, United States, 47710

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1; Dose regimen 1 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)
EXPERIMENTAL: Cohort 2; Dose regimen 2 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)
EXPERIMENTAL: Cohort 3; Dose regimen 3 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)
EXPERIMENTAL: Cohort 4; Dose regimen 4 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)
EXPERIMENTAL: Cohort 5; Dose regimen 5 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; 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 A; 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 A; 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: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)
EXPERIMENTAL: Cohort 9; Dose regimen 9 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of TEAEs	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).	Day 1 to Day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration	To characterize the pharmacokinetic (PK) profile (i.e. serum concentration) of IV and SC doses of REGN1033.	Baseline to End of Study (Day 113)
Immunogenicity	To assess the potential for immunogenicity following IV and SC doses of REGN1033.	Baseline to End of Study (Day 113)

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (ESTIMATE): January 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 12, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: R1033-HV-1107