|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Acceleron Pharma, Inc. |
|---|---|
| Information provided by: | Acceleron Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT00755638 |
Purpose
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 |
| Enrollment: | 48 |
| Study Start Date: | September 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 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
|
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Acceleron Pharma Inc. ( Niels Borgstein, MD ) |
| Study ID Numbers: | A031-01 |
| Study First Received: | September 17, 2008 |
| Last Updated: | July 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00755638 History of Changes |
| Health Authority: | Canada: Health Canada |