NCT01910220CompletedPhase 1
Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 125
- Primary Endpoint
- Percent change in total lean mass
Study Overview
Brief Summary
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Group 1
Placebo Comparator
placebo
Intervention: placebo (Other)
Group 2
Experimental
REGN1033 (SAR391786)
Intervention: REGN1033 (SAR391786) (Drug)
Group 3
Placebo Comparator
placebo + exercise regimen
Intervention: placebo (Other)
Group 4
Experimental
REGN1033 (SAR391786) + exercise regimen
Intervention: REGN1033 (SAR391786) (Drug)
Outcomes
Primary Outcomes
Percent change in total lean mass
Time Frame: At week 12
The primary endpoint is percent change in total lean mass at week 12 (day 85)
Secondary Outcomes
- Number of TEAEs(day 1 to day 141)
- Appendicular lean mass by DXA(At week 12)
Investigators
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