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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

This is a study to assess the safety and tolerability of subcutaneously administered REGN1033 (SAR391786) in healthy volunteers.

Key facts

Study ID

NCT01720576

Run by

Regeneron Pharmaceuticals

People needed

60

Starts

2012-10-01

Expected to finish

2013-06-01

Last updated by the study team

2013-09-12

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligible subjects are males and females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
• A subject must meet the following criteria to be eligible for inclusion in the study:
• Sexually active males willing to use contraceptives during the study and through 4 months after the study.
• Female subjects not of child bearing potential (surgically sterile or postmenopausal for longer than 1 year)
• Body mass index (BMI) between 18.5 and 32 kg/m2 inclusive
• Willing to maintain current diet and exercise routine for the duration of the study
• 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 such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
• Evidence of malnutrition
• Cachexia of any cause
• Evidence or history of muscle diseases or weakness with the exception of age related muscle loss
• Limb amputation
• Immobilization, surgical procedure, fracture, or trauma to the upper or lower limb within 6 months
• History or evidence of heart diseases including but not limited to coronary heart disease with/without history of myocardial infarction, chronic or acute heart failure (New York Heart Association [NYHA] stage 2-4), cardiac arrhythmia with clinical symptoms, valvular heart disease, and cardiac hypertrophy of clinical significance
• Women of childbearing potential (not surgically sterile or amenorrheic for at least 12 months if postmenopausal)
• Uncontrolled diabetes defined as HbA1C > 7.5 at screening; if taking oral hypoglycemic drugs, have to be on stable doses of medication for more than 3 months. Diabetics using insulin are excluded
• Asthmatic subjects with current or recurring symptoms within 1 year.
• History of, COPD, chronic kidney disease, cancer except primary basal-cell skin cancer that has been adequately treated
• Neurological injury (eg, stroke) within 1 year
• Abnormal or uncontrolled blood pressure at screening visit defined as diastolic BP >95 and/or systolic BP >160 mm Hg; if taking hypertensive medication, have to be on stable doses of medication for more than 3 months
• Hepatic transaminases (ALT and or AST) > 2X ULN
• Reduced renal function as defined by eGFR<60 mL/min
• Current smokers or previous smokers who stopped smoking within 6 months
• Current or recent history (within 1 year of screen) of alcohol or drug abuse
• History of hypersensitivity response to any biologics
• History of hypersensitivity to doxycycline or other tetracycline antibiotics
• Current or recent participation in any clinical trial (within 30 days of small molecular drugs or within 3 months of biologics)
• Exposure within 3 months to approved biological drugs. (The name of the drug and duration of previous exposure will be recorded). Vaccines are allowed.
• Sexually active men* who are unwilling to practice adequate contraception during the study

Where it is running

• Study site — Daytona Beach, Florida, United States
• Study site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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