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 |
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
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
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