NCT00755638

A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers

Conditions

• Muscle Loss

Interventions

Type	Name	Description
BIOLOGICAL	ACE-031	single subcutaneous dose of ACE-031

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-09-19
• Last updated: 2009-07-14

Locations

1 site across 1 country: Canada