Study of ACE-536 in Healthy Postmenopausal Women

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-536 in Healthy Postmenopausal Women

The purpose of this study is to find out whether ACE-536 can be safely given to patients. This study will also look to see if ACE-536 increases red blood cells, the cells that carry oxygen in the body.

Key Inclusion Criteria:

• Postmenopausal women
• Body Mass Index (BMI) of 20 - 32 kg/m2.

Key Exclusion Criteria:

• History of hypertension
• Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1
• History of clinically significant cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other disease
• Surgery within 3 months (other than minor cosmetic surgery or minor dental procedures)
• Subject has received treatment with another investigational drug, or approved therapy for investigational use within 1 month prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Day 1, whichever is longer