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

NCT01507402 | Completed Phase 1 DMC

• 1 other identifier: R1033-HV-1107
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Serum concentration

  Baseline to End of Study (Day 113)

• Immunogenicity

  Baseline to End of Study (Day 113)

Study Arms (9)

Cohort 1

EXPERIMENTAL

Dose regimen 1 (Participants 18 to ≤ 65 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Cohort 2

EXPERIMENTAL

Dose regimen 2 (Participants 18 to ≤ 65 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Cohort 3

EXPERIMENTAL

Dose regimen 3 (Participants 18 to ≤ 65 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Cohort 4

EXPERIMENTAL

Dose regimen 4 (Participants 18 to ≤ 65 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Cohort 5

EXPERIMENTAL

Dose regimen 5 (Participants 18 to ≤ 65 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Cohort 6

EXPERIMENTAL

Dose regimen 6 (Participants 18 to ≤ 65 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Cohort 7

EXPERIMENTAL

Dose regimen 7 (Participants 18 to ≤ 65 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Cohort 8

EXPERIMENTAL

Dose regimen 3 (Participants \> 65 to ≤ 85 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Cohort 9

EXPERIMENTAL

Dose regimen 9 (Participants 18 to ≤ 65 yrs old)

Drug: REGN1033(SAR391786); Drug: Placebo

Interventions

REGN1033(SAR391786) DRUG

Administration method A

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 8; Cohort 9

Placebo DRUG

(inactive substance)

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• History of muscle neoplasms such as rhabdomyoma, rhabdomyosarcoma, leiomyoma, leiomyosarcoma or uterine fibroid tumors
• History of muscular dystrophy, myositis, and other primary diseases of skeletal muscle
• 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
• History of systemic hypertension or use of concomitant medications to treat hypertension, or history of pulmonary hypertension
• History of diabetes mellitus or gestational diabetes or use of concomitant medications for treatment of these
• Recent use of androgenic steroids
• Unexplained creatine phosphokinase (CPK) levels \>3X upper limit of normal.
• 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
• Women of childbearing potential (not surgically sterile or amenorrheic for at least twelve months if postmenopausal)
• 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
• 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
• Positive urine drug test results during screening or history of drug or alcohol abuse within a year prior to the screening visit
• Any hospitalization within 60 days prior to the screening visit
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (2)

Unknown Facility

Honolulu, Hawaii, United States

Location

Unknown Facility

Evansville, Indiana, 47710, United States

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (2)