Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
- Registration Number
- NCT02943239
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
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/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel A REGN2477 REGN1033 + REGN2477 (Regimen 1) or placebo Panel A Placebo REGN1033 + REGN2477 (Regimen 1) or placebo Panel B Placebo Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo Panel B REGN2477 Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo Panel C REGN1033 Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo Panel C REGN2477 Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo Panel C Placebo Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo Panel D REGN2477 Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo Panel D Placebo Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo Panel E REGN2477 REGN2477 (Regimen 5) or placebo Panel E Placebo REGN2477 (Regimen 5) or placebo Panel F REGN1033 REGN2477 + REGN1033 (Regimen 6) or placebo Panel F REGN2477 REGN2477 + REGN1033 (Regimen 6) or placebo Panel F Placebo REGN2477 + REGN1033 (Regimen 6) or placebo Panel G REGN2477 REGN2477 (Regimen 7) or placebo Panel G Placebo REGN2477 (Regimen 7) or placebo Panel A REGN1033 REGN1033 + REGN2477 (Regimen 1) or placebo Panel B REGN1033 Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo Panel D REGN1033 Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo
- Primary Outcome Measures
Name Time Method Incidence and severity of treatment-emergent adverse events (TEAEs) Up to 40 weeks
- Secondary Outcome Measures
Name Time Method Change in total body composition as measured by DXA Up to 28 weeks Change in total GDF8 levels in blood Up to 32 weeks 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 regional body composition as measured by DXA Up to 28 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 Activin A levels in blood Up to 40 weeks Presence or absence of antibodies against REGN2477 and REGN1033 Up to 40 weeks