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

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