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Study of ACE-536 in Healthy Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01432717
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Biological: ACE-536 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : September 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
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.




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
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

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.

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 Posted: September 13, 2011    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012