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

Use our guide to learn which trials are right for you!

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
Fresh Meadows, New York 11365
?
mi
from 91732
Fresh Meadows, NY
Click here to add this to my saved trials
Astoria, New York 11102
?
mi
from 91732
Astoria, NY
Click here to add this to my saved trials
Augusta, Georgia 30909
?
mi
from 91732
Augusta, GA
Click here to add this to my saved trials
9730 South Western Avenue
Chicago, Illinois 60643
1725
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Great Neck, New York 11021
2446
mi
from 91732
Great Neck, NY
Click here to add this to my saved trials
Hollywood, Florida 33020
2317
mi
from 91732
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77099
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
North Brunswick, New Jersey 08902
?
mi
from 91732
North Brunswick, NJ
Click here to add this to my saved trials
Northridge, California 91324
32
mi
from 91732
Northridge, CA
Click here to add this to my saved trials
Providence, Rhode Island 02915
?
mi
from 91732
Providence, RI
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
Tampa, Florida 33614
?
mi
from 91732
Tampa, FL
Click here to add this to my saved trials