Study of ACE-536 in Healthy Postmenopausal Women
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | September 2011 |
| End Date: | June 2012 |
| Contact: | Trial Manager |
| Email: | clinicaltrials@acceleronpharma.com |
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
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