Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Acceleron Pharma, Inc. |
---|---|
Information provided by: | Acceleron Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00755638 |
Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers
Condition | Intervention | Phase |
---|---|---|
Muscle Loss |
Biological: ACE-031 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy, Postmenopausal Volunteers |
Estimated Enrollment: | 48 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
single: Experimental
8 subjects (6 active and 2 placebo)
|
Biological: ACE-031
single subcutaneous dose of ACE-031
|
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contact: Richard Larouche, MD | (514) 485-7500 | rlarouche@anapharm.com |
Canada, Quebec | |
Acceleron Investigative Site | Recruiting |
Montreal, Quebec, Canada |
Responsible Party: | Acceleron Pharma Inc. ( Niels Borgstein, MD ) |
Study ID Numbers: | A031-01 |
Study First Received: | September 17, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00755638 |
Health Authority: | Canada: Health Canada |
Healthy |