Status:
COMPLETED
Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Healthy Volunteers
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.
Eligibility Criteria
Inclusion
- Males and postmenopausal females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
- Low activity lifestyle
- Diet and exercise adherence
Exclusion
- Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
- Participation in any clinical trial within 6 months prior to screening.
- Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period.
- Limb amputation (except for toes) and/or any fracture within 6 months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01910220
Start Date
August 1 2013
End Date
October 1 2014
Last Update
November 10 2014
Active Locations (5)
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1
Gainesville, Florida, United States
2
Orlando, Florida, United States
3
Boston, Massachusetts, United States
4
St Louis, Missouri, United States