Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

A Phase 1, Open-label, Single-dose Study of Romosozumab (AMG 785) Administered Subcutaneously to Healthy Subjects and Subjects With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients with stage 4 renal impairment (RI) or stage 5 RI requiring hemodialysis.

INCLUSION CRITERIA - ALL SUBJECTS :

• Males or females ≥ 50 years of age
• Body weight ≥ 45 and ≤ 110 kg
• Willing to adhere to calcium and vitamin D supplementation requirements
• Females must be of non-reproductive potential

INCLUSION CRITERIA - SUBJECTS WITH RENAL IMPAIRMENT (GROUPS 1 AND 2):

• Group 1 - Stage 4 RI (estimated glomerular filtration rate (eGFR) 15-29 mL/min/1.73 m²)
• Group 2 - End stage renal disease requiring hemodialysis

INCLUSION CRITERIA - HEALTHY SUBJECTS (GROUP 3):

• Renal function defined as an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73 m²

EXCLUSION CRITERIA - ALL SUBJECTS:

• History of metabolic or bone disease (except for metabolic bone disease in renal impairment (RI) subjects)
• History of osteoporosis, vertebral fracture, or fragility fracture of the wrist, humerus, hip, or pelvis after age 50
• Recent bone fracture
• Vitamin D insufficiency
• Hypocalcemia or hypercalcemia
• Hypomagnesemia
• Hypophosphatemia
• Untreated hyper- or hypothyroidism
• Females with a positive pregnancy test
• Males with pregnant partners
• Females who are lactating/breastfeeding or plan to breastfeed on study and for 3 months after receiving the dose of study drug
• History of spinal stenosis
• History of facial nerve paralysis
• Positive for human immunodeficiency virus (HIV) antibodies
• Positive for hepatitis B surface antigen or detectable hepatitis C
• Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical, or breast ductal carcinoma in situ) within 5 years before screening
• History of solid organ or bone marrow transplants EXCLUSION CRITERIA - HEALTHY SUBJECTS (GROUP 3)
• Current hyper- or hypoparathyroidism