Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men

Launched by REGENERON PHARMACEUTICALS · Oct 21, 2016

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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/Exclusion criteria apply.