CompletedInterventionalPhase 1Updated Nov 26, 2019
A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786) | NCT01507402 | Trialant
CompletedInterventionalPhase 1Updated Nov 14, 2012
A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)
ClinicalTrials.gov ID
NCT01507402
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
76Actual
Last Update Posted
Nov 14, 2012Estimated
Start Date
Jan 2012
Primary Completion Date
Nov 2012Actual
Completion Date
Nov 2012Actual
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.
Healthy Volunteers
REGN1033(SAR391786)
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
History of a hypersensitivity reaction to doxycycline or to other tetracycline drugs
Previous exposure to any biological therapeutic agent, excepting vaccines