Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2011-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ACE-536
Subjects assigned to 1 of 5 possible dosing groups.
ACE-536
Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.
Placebo
Placebo
Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.
Interventions
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ACE-536
Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.
Placebo
Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 20 - 32 kg/m2.
Exclusion Criteria
* 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
45 Years
75 Years
FEMALE
Yes
Sponsors
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Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY
Responsible Party
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Locations
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Acceleron Investigative Site
Tempe, Arizona, United States
Countries
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References
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Attie KM, Allison MJ, McClure T, Boyd IE, Wilson DM, Pearsall AE, Sherman ML. A phase 1 study of ACE-536, a regulator of erythroid differentiation, in healthy volunteers. Am J Hematol. 2014 Jul;89(7):766-70. doi: 10.1002/ajh.23732. Epub 2014 Apr 26.
Other Identifiers
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A536-02
Identifier Type: -
Identifier Source: org_study_id