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

History of Changes

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 May 21, 2013

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