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
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 April 17, 2014