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Study of ACE-536 in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432717
First Posted: September 13, 2011
Last Update Posted: November 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Acceleron Pharma, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

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 ]

Secondary Outcome Measures:
  • ACE-536 serum concentration after single and multiple ascending doses. [ Time Frame: 22 weeks ]
  • Hemoglobin levels after single and multiple ascending doses. [ Time Frame: 22 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432717


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01432717     History of Changes
Other Study ID Numbers: A536-02
First Submitted: September 1, 2011
First Posted: September 13, 2011
Last Update Posted: November 7, 2012
Last Verified: November 2012