Phase 2 Study of Apixaban Reversal by Ciraparantag as Measured by WBCT

Exclusion Criteria

• •1. History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal (including gallbladder disease or surgery), hematologic, or oncologic disease as determined by screening history, physical examination, laboratory test results or 12-lead ECG assessment. History or current evidence of liver function tests greater than 50% of the upper limit of normal (ULN) or renal function tests (serum creatinine) greater than 1.5 mg/dl and based on PI discretion. History or current evidence of QTc (QTcF) greater than normal (450 msec for males or 470 msec for females).
• •2. History of unexplained syncope
• •3. History of major bleeding, trauma, or surgical procedure of any type based on PI discretion
• •4. Vaginal delivery within six months prior to screening
• •5. History of peptic ulcer, gastrointestinal bleeding (including hematemesis, melena, rectal bleeding) within one year prior to screening
• •6. Long standing history of bleeding episodes such as epistaxis, bruising or gingival bleeding or if not long standing, within 1 month prior to screening
• •7. Personal or family history of clotting disorder or abnormality, excessive bleeding, joint hematoma, thrombovascular disease or any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, or history of thrombocytopenia
• •8. Females with a history of dysfunctional uterine bleeding who have not undergone hysterectomy, including history of menorrhagia (heavy menstrual bleeding), menometrorrhagia or polymenorrhea
• •9. Smokers or use of tobacco and/or nicotine containing products within 3 months prior to dosing as determined by the subject's verbal history
• •10. Pregnant or breast-feeding
• •11. Males with a history of hormone therapy within 3 months prior to screening
• •12. Taking any type of chronic medication (including vitamin, nutritional and herbal supplements) for more than 14 consecutive days within the 4 weeks prior to study entry (use of hormonal contraceptives is acceptable except for oral contraceptives)
• •13. Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus antibody (HCV-Ab), or Hepatitis B surface antigen (HBsAg)
• •14. Donation of blood or blood products within 56 days prior to screening
• •15. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
• •16. Active drug or alcohol dependence within the prior 12 months or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol
• •17. Allergic to apixaban