Lead Sponsor

Veloxis Pharmaceuticals

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•18 years of age or older
•Unresectable metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
•ECOG performance status of 0 or 1
•The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges
•Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
•Able to sufficiently understand the clinical study and give written informed consent

•Prior treatment history with nerve toxic chemotherapeutic agent
•Peripheral neuropathy or central nervous system damage
•Psychiatric disorder
•History of major hemorrhage
•High risk of hemorrhage
•History of other malignancies
•Active ulcer
•Patients using anti-coagulants and fibrinolytic drugs
•Active Hepatitis B, or known HBs antigen positive
•Prior treatment history with thrombomodulin alfa
•Administration of another investigational medicinal product within 30 days prior to randomization
•Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
•Patients otherwise deemed as inappropriate to participate in the study by the Investigator

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