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

Acceleron Pharma

Status and phase

Completed

Phase 1

Conditions

Muscle Loss

Treatments

Biological: ACE-031

Study type

Interventional

Funder types

Industry

Identifiers

NCT00755638

A031-01

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

Female

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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).
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.