We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00952887
First Posted: August 6, 2009
Last Update Posted: March 23, 2011
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.
Information provided by:
Acceleron Pharma, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031 [ Time Frame: 6.5 months ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Richard Larouche, MD, Anapharm Inc.
ClinicalTrials.gov Identifier: NCT00952887     History of Changes
Other Study ID Numbers: A031-02
First Submitted: August 4, 2009
First Posted: August 6, 2009
Last Update Posted: March 23, 2011
Last Verified: March 2011

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