Healthy Volunteers
Conditions
Brief summary
The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033. The secondary objectives are to: * Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume * Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on total and regional body composition * Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033 * Assess immunogenicity of REGN2477 or REGN1033 * Assess REGN2477 or REGN1033 target engagement
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Postmenopausal women age 45 to 70 years and age 35 to 60 years inclusive for men not intending to father children * BMI between 18 to 32 kg/m2, inclusive * Willing and able to maintain current diet, supplements and physical activity level throughout the study * Provides signed informed consent Key
Exclusion criteria
* Significant illness or history of significant illness * Contraindication to MRI * History of human immunodeficiency virus (HIV); hepatitis B or hepatitis C virus (HCV) * History of immobilization, major surgical procedure, fracture, or major trauma within 9 months prior to screening * History of significant gynecological disorders or malignancies; history of breast malignancies (uterine fibroids or dysfunctional uterine bleeding is acceptable) * Inconsistent vigorous physical activity (on fewer than 5 days per week), such as intermittent weight lifting * History of hypersensitivity reactions to tetracycline antibiotics (includes doxycycline), vaccines, or biologics * Use of agents that alter muscle mass that have not been at a stable dose for 3 months prior to screening (includes protein supplements), or use of any weight altering or anabolic steroid drugs (includes drugs for obesity, diuretics, testosterone) * Participants treated with a biologic therapy or biologic immunotherapy in the previous 12 weeks prior to screening and during the study Note: Other protocol Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Up to 40 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in thigh muscle volume as measured by MRI | Up to 28 weeks |
| Change in thigh muscle volume as measured by MRI | Up to 28 weeks |
| Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA) | Up to 28 weeks |
| Change in total body composition as measured by DXA | Up to 28 weeks |
| Change in total Activin A levels in blood | Up to 40 weeks |
| Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time | Up to 40 weeks |
| Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime | Up to 40 weeks |
| Change in total GDF8 levels in blood | Up to 32 weeks |
| Presence or absence of antibodies against REGN2477 and REGN1033 | Up to 40 weeks |
| Change in regional body composition as measured by DXA | Up to 28 weeks |
Countries
New Zealand
Outcome results
None listed