Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults

Eligibility Criteria

• 1. Provide written informed consent.
• 2. 18 to 75 years of age.
• 3. Be in generally good health
• 4. BMI 18 to 32 kg/m2, inclusive, at Screening.
• 5. If female, be surgically sterile or post-menopausal or if of child-bearing potential, using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1.
• 6. If male, be surgically sterile, or agree to use appropriate contraception.
• 7. Have suitable venous access for multiple venipunctures.
• 1. Have any of the following findings at Screening:
• 1. Hemoglobin or hematocrit value outside the normal range
• 2. Platelet count outside the normal range
• 3. PT or aPTT outside the normal range
• 4. Plasma fibrinogen outside the normal range
• 5. Serum triglycerides or total cholesterol outside the normal range
• 6. Serum creatinine \>1.5 mg/dL (133 μmol/L) or known renal disease
• 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 x the upper limit of normal, or known liver disease
• 8. Total bilirubin outside the normal range
• 9. Positive viral screen for hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
• 10. Positive pregnancy test (females)
• 11. Positive drug, tobacco or alcohol screen
• 12. Any clinically significant findings on 12-lead ECG or urinalysis
• 2. Have a personal or family history of clotting disorder or hematologic abnormality.
• 3. Have a history of unexplained syncope.
• 4. Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure of any type, or vaginal delivery
• 5. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding.
• 6. Have received any blood product or anticoagulant within 3 months prior to Screening.
• 7. Have donated blood or blood products within 3 months prior to Screening
• 8. Have a history of minor bleeding episodes within 1 month prior to Screening, or a long-standing history of such bleeding.
• 9. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
• 10. Have used any tobacco or nicotine-containing products within 3 months prior to Screening.
• 11. Have used any systemic prescription or non-prescription drugs within 14 days prior to Day 1 (except for permitted contraceptives).
• 12. If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
• 13. Have received ciraparantag in any prior clinical study.
• 14. Have received another investigational drug within 5 half-lives or 30 days, whichever is longer, prior to Day 1.
• 15. Known allergy to edoxaban, apixaban or rivaroxaban.
• 16. Have any other condition that, in the opinion of the Investigator, would interfere with a subject's ability to adhere to the protocol, interfere with assessment of the investigational product, or compromise the safety of the subject or the quality of the data.