Study of ACE-536 in Healthy Postmenopausal Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01432717|
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : November 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Biological: ACE-536 Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||October 2012|
Subjects assigned to 1 of 5 possible dosing groups.
Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.
|Placebo Comparator: Placebo||
Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.
- Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: 22 weeks ]
- ACE-536 serum concentration after single and multiple ascending doses. [ Time Frame: 22 weeks ]
- Hemoglobin levels after single and multiple ascending doses. [ Time Frame: 22 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432717
|United States, Arizona|
|Acceleron Investigative Site|
|Tempe, Arizona, United States|