A First-in-human Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women

Inclusion Criteria: * Healthy males and females between 45 to 65 years of age * Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result \> 40mIU/mL, or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) * Men must agree to use highly effective methods of contraception; males must agree to not donate sperm for the entire study and 7 months after the end of treatment * Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in) * Has no history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion * Negative urine screen for potential drugs of abuse at screening and admission, unless medication is prescribed by a physician Exclusion Criteria: * Healthy males with partners who are pregnant at the time of screening; or healthy males with partners who plan to become pregnant during the study * Osteoporosis, as defined by BMD t-scores of the lumbar spine (L1-L4) or total evaluable vertebrae; or femoral neck ≤ 2.5 * Diagnosed with any condition that will affect bone metabolism * Diagnosis of clotting factor deficiency or history of bleeding or coagulation disorder (including history of heparin or warfarin administration) * Subjects with fewer than 2 evaluable vertebrae; metal in hips bilaterally that would not allow for at least one evaluable hip; metal in forearms bilaterally that would not allow for at least one evaluable forearm * Abnormal international normalized ratio or partial thromboplastin time * Administration of the following medications within 6 months before study drug administration: * Hormone replacement therapy \[Infrequent use of estrogen vaginal creams (\< 3 times per week) is allowed.\] * Calcitonin * Parathyroid hormone (or any derivative) * Supplemental Vitamin D \> 1,000 IU/day * Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed) * Anabolic steroids * Calcitriol, and available analogues * Administration of the following medications within 12 months before study drug administration: * Bisphosphonates * Fluoride for osteoporosis * Administration of herbal medications within 2 weeks or 5 half-lives (whichever is longer) before study drug administration * Greatly differing levels of physical activity or constant levels of intense physical exercise during the 6 months before study drug administration * Known alcohol abuse or use of illicit drugs within 12 months of admission * Unwilling or unable to limit alcohol consumption throughout the course of the study * Known sensitivity to mammalian-derived drug preparations * Known to be hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus positive, or a known diagnosis of acquired immunodeficiency syndrome * An unstable medical condition, defined as having been hospitalized within 28 days before day -1, major surgery within 6 months before day -1, or otherwise unstable in the judgment of the investigator * Has any clinically significant abnormality during the screening physical examination, ECG, or laboratory evaluation * Unavailable for follow-up assessment or any concerns for subject's compliance with the protocol procedures * Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent * Has participated in another clinical study within 4 weeks of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known * Has donated or lost 400 mL or more of blood or plasma within 8 weeks of study drug administration * Previous exposure to AMG 785