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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755638
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : July 14, 2009
Information provided by:
Acceleron Pharma, Inc.

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

Condition or disease Intervention/treatment Phase
Muscle Loss Biological: ACE-031 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: single
8 subjects (6 active and 2 placebo)
Biological: ACE-031
single subcutaneous dose of ACE-031

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers [ Time Frame: specified timepoints in the protocol ]

Secondary Outcome Measures :
  1. To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031 [ Time Frame: specified timepoints in the protocol ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia).
  5. Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening.
  6. Subject has a history of severe allergic or anaphylactic reactions.
  7. Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures).
  8. Subject had a fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing.
  9. Subject has a positive Tuberculin skin test (Mantoux)
  10. Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV).
  11. 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.
  12. Subject consumed any alcohol within 48 hours prior to dosing.
  13. Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration.
  14. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00755638

Canada, Quebec
Acceleron Investigative Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Acceleron Pharma, Inc.

Responsible Party: Niels Borgstein, MD, Acceleron Pharma Inc. Identifier: NCT00755638     History of Changes
Other Study ID Numbers: A031-01
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009