Desidustat in the Treatment of Chemotherapy Induced Anemia

Exclusion Criteria

• •1. Known hypersensitivity to Desidustat and excipients in the investigational drug product.
• •2. History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the time of screening.
• •3. History of RBC transfusion \<4 weeks prior enrollment.
• •4. History or presence of any clinically significant electrocardiogram abnormalities during screening.
• •5. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (e.g., deep vein thrombosis (DVT) or pulmonary embolism) within previous 6 months of screening
• •6. Major illness and/or major surgery in the last 3 months.
• •7. Planned elective surgery during the study
• •8. Receiving or has received any investigational drug within the 30 days before receiving Desidustat.
• •9. Any participants with poor peripheral venous access.
• •10. A positive test result for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening visit.
• •11. Female patients with following criteria will not be recruited:
• •* History of pregnancy or lactation in the past 3 months
• •* Fertile female volunteers not protected against pregnancy by adequate long-term antifertility measures
• •* History of less than 1 year of menopause and not using adequate long-term anti-fertility measures
• •* Using hormone replacement therapy
• •* Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
• •* Positive serum β-hCG level at the screening visit
• •12. Abnormal baseline laboratory investigations as follows:
• •* WBC count ≤ 3 x 103/uL
• •* Platelets count ≤ 100 x 103/uL
• •* Bilirubin ≥ 1.5 mg/dL
• •* ALT and/or AST ≥ 2.5 times of the ULN.