A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00952887
First received: August 4, 2009
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.


Condition Intervention Phase
Muscular Atrophy
Biological: ACE-031
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy Postmenopausal Women

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

Primary Outcome Measures:
  • To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women [ Time Frame: 6.5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031 [ Time Frame: 6.5 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: August 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACE-031
8 dosing groups
Biological: ACE-031
Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months.
Other Name: ActRIIB-IgG1
Placebo Comparator: Placebo Biological: Placebo
Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months.

  Eligibility

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

Inclusion Criteria:

  • Postmenopausal
  • Body mass index (BMI) of ≥ 18.5 to < 32.

Exclusion Criteria:

  • History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas
  • History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
  • History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
  • Surgery within 3 months prior to Day 1 (other than minor cosmetic or dental procedures).
  • Fever or symptomatic viral or bacterial infection within 7 days prior to Day 1.
  • Donation or significant loss of blood within 2 months prior to Day 1.
  • Hormone replacement therapy within 3 months prior to Day 1.
  • Treatment with erythropoiesis stimulating agents (Epogen, Procrit, Aranesp, etc) within 2 months prior to Day 1.
  • Systemic glucocorticoid therapy within 6 months prior to Day 1.
  • Treatment with another investigational drug or approved therapy for investigational use within 1 month prior to Day 1.
  • Previous treatment with ACE-031.
  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: NCT00952887

Locations
Canada
Acceleron Investigative Site
Montreal, Canada
Acceleron Investigative Site
Quebec City, Canada
Sponsors and Collaborators
Acceleron Pharma, Inc.
Investigators
Principal Investigator: Richard Larouche, MD Anapharm
  More Information

No publications provided

Responsible Party: Richard Larouche, MD, Anapharm Inc.
ClinicalTrials.gov Identifier: NCT00952887     History of Changes
Other Study ID Numbers: A031-02
Study First Received: August 4, 2009
Last Updated: March 22, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Muscular Atrophy
Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014