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

This study has been completed.
Sponsor:
Information provided by:
Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00755638
First received: September 17, 2008
Last updated: July 10, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Muscle Loss
Biological: ACE-031
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Acceleron Pharma, Inc.:

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

Secondary Outcome Measures:
  • To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031 [ Time Frame: specified timepoints in the protocol ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single
8 subjects (6 active and 2 placebo)
Biological: ACE-031
single subcutaneous dose of ACE-031

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755638

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

No publications provided

Responsible Party: Niels Borgstein, MD, Acceleron Pharma Inc.
ClinicalTrials.gov Identifier: NCT00755638     History of Changes
Other Study ID Numbers: A031-01
Study First Received: September 17, 2008
Last Updated: July 10, 2009
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on April 16, 2014