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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014