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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

August 4, 2009
March 22, 2011
August 2009
February 2011   (final data collection date for primary outcome measure)
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 ]
To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women [ Time Frame: 5.5 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00952887 on ClinicalTrials.gov Archive Site
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 ]
To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031 [ Time Frame: 5.5 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Muscular Atrophy
  • 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
  • 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.
  • Experimental: ACE-031
    8 dosing groups
    Intervention: Biological: ACE-031
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Female
45 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00952887
A031-02
Yes
Richard Larouche, MD, Anapharm Inc.
Acceleron Pharma, Inc.
Not Provided
Principal Investigator: Richard Larouche, MD Anapharm
Acceleron Pharma, Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP