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

March 22, 2011 updated by: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
        • Acceleron Investigative Site
      • Quebec City, Canada
        • Acceleron Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • ActRIIB-IgG1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women
Time Frame: 6.5 months
6.5 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Investigators

  • Principal Investigator: Richard Larouche, MD, Anapharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 4, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

March 23, 2011

Last Update Submitted That Met QC Criteria

March 22, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A031-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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