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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 7, 2012
November 1, 2012
1 year
September 1, 2011
November 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with Adverse Events as a measure of safety and tolerability.
22 weeks
Secondary Outcomes (2)
ACE-536 serum concentration after single and multiple ascending doses.
22 weeks
Hemoglobin levels after single and multiple ascending doses.
22 weeks
Study Arms (2)
ACE-536
EXPERIMENTALSubjects assigned to 1 of 5 possible dosing groups.
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women
- Body Mass Index (BMI) of 20 - 32 kg/m2.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Acceleron Investigative Site
Tempe, Arizona, United States
Related Publications (1)
Attie KM, Allison MJ, McClure T, Boyd IE, Wilson DM, Pearsall AE, Sherman ML. A phase 1 study of ACE-536, a regulator of erythroid differentiation, in healthy volunteers. Am J Hematol. 2014 Jul;89(7):766-70. doi: 10.1002/ajh.23732. Epub 2014 Apr 26.
PMID: 24715706DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 13, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
November 7, 2012
Record last verified: 2012-11