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Study of ACE-536 in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01432717
First received: September 1, 2011
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to find out whether ACE-536 can be safely given to patients. This study will also look to see if ACE-536 increases red blood cells, the cells that carry oxygen in the body.


Condition Intervention Phase
Anemia
 Biological: ACE-536
Other: 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 Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-536 in Healthy Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Anemia
U.S. FDA Resources

Further study details as provided by Acceleron Pharma, Inc.:

Primary Outcome Measures:
  • Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ACE-536 serum concentration after single and multiple ascending doses. [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Hemoglobin levels after single and multiple ascending doses. [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACE-536
Subjects assigned to 1 of 5 possible dosing groups.
 Biological: ACE-536
Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.
Placebo Comparator: Placebo Other: Placebo
Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Postmenopausal women
  • Body Mass Index (BMI) of 20 - 32 kg/m2.

Key Exclusion Criteria:

  • History of hypertension
  • Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1
  • History of clinically significant cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other disease
  • Surgery within 3 months (other than minor cosmetic surgery or minor dental procedures)
  • Subject has received treatment with another investigational drug, or approved therapy for investigational use within 1 month prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Day 1, whichever is longer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432717

Locations
United States, Arizona
Acceleron Investigative Site
Tempe, Arizona, United States
Sponsors and Collaborators
Acceleron Pharma, Inc.
  More Information

No publications provided

Responsible Party: Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01432717     History of Changes
Other Study ID Numbers: A536-02
Study First Received: September 1, 2011
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013