Study of ACE-536 in Healthy Postmenopausal Women
Phase 1
Completed
- Conditions
- Anemia
- Registration Number
- NCT01432717
- Lead Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events as a measure of safety and tolerability. 22 weeks
- Secondary Outcome Measures
Name Time Method ACE-536 serum concentration after single and multiple ascending doses. 22 weeks Hemoglobin levels after single and multiple ascending doses. 22 weeks
Trial Locations
- Locations (1)
Acceleron Investigative Site
🇺🇸Tempe, Arizona, United States
Acceleron Investigative Site🇺🇸Tempe, Arizona, United States