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

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA1 site in 1 country48 target enrollmentSeptember 2008

ConditionsMuscle Loss

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Muscle Loss
Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Enrollment: 48
Locations: 1
Primary Endpoint: To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

July 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Eligibility Criteria

Inclusion Criteria

•Subject is a postmenopausal woman, 45-75 years old (inclusive)
•Subject has a body mass index (BMI) of \> 18.5 to \< 30
•Subject must give written informed consent

Exclusion Criteria

•Subject has a history of malignancy. However, a subject with a history of excised or treated basal cell carcinoma, cervical carcinoma in-situ, or less than or equal to 2 squamous cell carcinomas is eligible to participate in this study.
•Subject has a history of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
•Subjects with chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety will be excluded unless the investigator does not have safety or compliance concerns at study entry.
•Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia).
•Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening.
•Subject has a history of severe allergic or anaphylactic reactions.
•Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures).
•Subject had a fever (body temperature \> 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing.
•Subject has a positive Tuberculin skin test (Mantoux)
•Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV).