a first-in-human study evaluating amg 167 in healthy men and postmenopausal women

Conditions: Osteopenia

Summary: the primary objective of this study is to determine the safety and tolerability of amg 167 following a single dose subcutaneous (sc) or intravenous (iv) administration in healthy men and postmenopausal women.


Eligibility criteria:
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

Keywords: amgen phase 1 first in human postmenopausal