A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)
NCT ID: NCT01507402
Last Updated: 2012-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
76 participants
INTERVENTIONAL
2012-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
Dose regimen 1 (Participants 18 to ≤ 65 yrs old)
REGN1033(SAR391786)
Administration method A
Placebo
(inactive substance)
Cohort 2
Dose regimen 2 (Participants 18 to ≤ 65 yrs old)
REGN1033(SAR391786)
Administration method A
Placebo
(inactive substance)
Cohort 3
Dose regimen 3 (Participants 18 to ≤ 65 yrs old)
REGN1033(SAR391786)
Administration method A
Placebo
(inactive substance)
Cohort 4
Dose regimen 4 (Participants 18 to ≤ 65 yrs old)
REGN1033(SAR391786)
Administration method A
Placebo
(inactive substance)
Cohort 5
Dose regimen 5 (Participants 18 to ≤ 65 yrs old)
REGN1033(SAR391786)
Administration method B
Placebo
(inactive substance)
Cohort 6
Dose regimen 6 (Participants 18 to ≤ 65 yrs old)
REGN1033(SAR391786)
Administration method B
Placebo
(inactive substance)
Cohort 7
Dose regimen 7 (Participants 18 to ≤ 65 yrs old)
REGN1033(SAR391786)
Administration method B
Placebo
(inactive substance)
Cohort 8
Dose regimen 3 (Participants \> 65 to ≤ 85 yrs old)
REGN1033(SAR391786)
Administration method A
Placebo
(inactive substance)
Cohort 9
Dose regimen 9 (Participants 18 to ≤ 65 yrs old)
REGN1033(SAR391786)
Administration method A
Placebo
(inactive substance)
Interventions
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REGN1033(SAR391786)
Administration method A
REGN1033(SAR391786)
Administration method B
Placebo
(inactive substance)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Honolulu, Hawaii, United States
Evansville, Indiana, United States
Countries
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Other Identifiers
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R1033-HV-1107
Identifier Type: -
Identifier Source: org_study_id