Status:
COMPLETED
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers
Lead Sponsor:
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions:
Muscle Loss
Eligibility:
FEMALE
45-75 years
Phase:
PHASE1
Brief Summary
Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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).
- Subject has a recent or clinically significant history of drug or alcohol abuse, or tests positive in a urine screen for alcohol or drugs of abuse.
- Subject consumed any alcohol within 48 hours prior to dosing.
- Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration.
- Subject has taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00755638
Start Date
September 1 2008
End Date
July 1 2009
Last Update
July 14 2009
Active Locations (1)
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1
Acceleron Investigative Site
Montreal, Quebec, Canada