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

- 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

- 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