Single-ascending dose of CEP 37251 in Healthy Postmenopausal Women

INTERVENTION: 5 subcutaneous injection doses (sequentially) of CEP‐37251 (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 subcutaneous injection doses have been studied, an intravenous infusion dose of 0.3 mg/kg will be studied. At each dose level, subjects will be divided into 3 cohorts. The first cohort will consist of 2 subjects (1 subject receiving CEP‐37251 and 1 subject receiving placebo), the second cohort will consist of 3 subjects (2 subjects receiving CEP‐37251 and 1 subject receiving placebo), and cohort 3 will consist of 4 subjects (3 subjects receiving CEP‐37251 and 1 subject receiving placebo). There will be a minimum of 30 minutes between the start of study drug administration for each subject within a cohort. Each subject in both the subcutaneous injection and intravenous infusion groups will receive one dose only. There will be a minimum of 1 week between dose administration of the 1st and subsequent cohort(s) for each dose level. There is no minumum wait time between administration of the 2nd and 3rd cohorts in each dose level. The 2nd and 3rd cohorts of a dose level can be dosed in non‐sequential order and can be dosed on the same day. CONDITION: Osteoporosis in Healthy Postmenopausal Women PRIMARY OUTCOME: The primary objective of this study is to assess the safety of CEP 37251 given by subcutaneous injection or intravenous infusion to healthy postmenopausal women SECONDARY OUTCOME: To evaluate the following characteristic of CEP‐37251 over 70 days following a single subcutaneous injection or an intravenous infusion to healthy postmenopausal women ; ‐ The pharmacodynamic effect of CEP‐37251 as measured by markers of bone metabolism To evaluate the following characteristic of CEP‐37251 over 70 days following a single subcutaneous injection or an intravenous infusion to healthy postmenopausal women ; ‐The pharmacokinetic profile of CEP‐37251 INCLUSION CRITERIA: 1. The subject is a postmenopausal woman aged 40 years or greater but less than 75 years. 2.The subject is considered to be postmenopausal if at least 1 of the following criteria is met: 1a) aged 50 or more years and has had a lack of menses for 12 or more months 1b) aged 40 or more and less than 50 years, has had a lack of menses for 12 or more months, and serum estradiol is 20 ng/mL or less or follicular stimulating hormone (FSH) is 50 IU/L or greater 1c) aged 40 or more years and has had bilateral surgical oophorectomy 1d) aged 40 or more years, has had a hysterectomy, and serum estradiol is 20 ng/mL or less or FSH is 50 IU/L or greater 3. The subject has a body weight greater than 50 kg but no more than 100 kg with a body mass index (BMI) of 18 to 35 kg/m2