Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 80
Updated:2/13/2019
Start Date:August 2016
End Date:December 2018

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A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety,
pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo


INCLUSION CRITERIA

1. Age greater than or equal to 18 years at the time of signing of the ICF.

2. The patient agrees to comply with the contraception and reproduction restrictions of
the study

3. Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents
(ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening

4. At least 2 ferritin values during Screening > 300 ng/mL

5. At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50%
(inclusive)

EXCLUSION CRITERIA:

1. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use
of such drugs any time during the study

2. Clinical evidence or suspicion of active or smoldering infection by clinical or
serologic criteria

3. Actively treated or active malignancy

4. Known or suspected occult or active bleeding

5. Received a red blood cell or whole blood transfusion within 2 months prior to
Screening or anticipated to receive a blood transfusion at any time during the study
We found this trial at
12
sites
North Brunswick, New Jersey 08902
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North Brunswick, NJ
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Astoria, New York 11102
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Astoria, NY
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Augusta, Georgia 30909
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Augusta, GA
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9730 South Western Avenue
Chicago, Illinois 60643
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Chicago, IL
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Fresh Meadows, New York 11365
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Fresh Meadows, NY
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Great Neck, New York 11021
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Great Neck, NY
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Hollywood, Florida 33020
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Hollywood, FL
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Houston, Texas 77099
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Houston, TX
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Northridge, California 91324
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Northridge, CA
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Providence, Rhode Island 02915
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Providence, RI
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San Antonio, Texas 78215
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San Antonio, TX
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Tampa, Florida 33614
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Tampa, FL
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