Healthy Volunteers
Conditions
Brief summary
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.
Interventions
OTHERplacebo
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males and postmenopausal females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values. 2. Low activity lifestyle 3. Diet and exercise adherence
Exclusion criteria
1. Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease. 2. Participation in any clinical trial within 6 months prior to screening. 3. Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period. 4. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in total lean mass | At week 12 | The primary endpoint is percent change in total lean mass at week 12 (day 85) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of TEAEs | day 1 to day 141 | Number of treatment-emergent adverse events (TEAEs) from day 1 (baseline) to day 141 (end of study) |
| Appendicular lean mass by DXA | At week 12 | Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12 |
Countries
United States
Outcome results
None listed