Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD

Exclusion Criteria

• •1. Evidence or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal (GI), cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, or psychiatric disease.
• •2. Any evidence or history of intracranial bleeding, aneurysm, or thrombotic or hemorrhagic stroke.
• •3. Any known individual or family history of a bleeding diathesis or coagulopathy.
• •4. Active or expected menstruation during the Treatment Phase (females only).
• •5. History of thrombocytopenia associated with abnormal bleeding or risk of a bleeding event, or screening or baseline platelet count \<100,000/mm3.
• •6. History of thrombocytosis associated with a thrombotic event or risk for a thrombotic event, or screening or baseline platelet count \>600,000/mm3.
• •7. Endoscopically confirmed peptic ulcer disease within 3 years of CRU admission or GI bleeding within 3 months of CRU admission, including a positive stool for occult blood at Screening or Baseline.
• •8. Urinary tract bleeding within 3 months of CRU admission, including microscopic hematuria on screening or baseline urinalysis.
• •9. Unusual or prolonged bleeding (e.g., gum bleeding, nosebleeds, easy bruising), as documented on the Self-Reported Bleeding Questionnaire, at Screening.
• •10. Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within 3 months of CRU admission.
• •11. Severe persistent hypertension (systolic pressure \>180 mmHg or diastolic pressure \>110 mmHg).
• •12. Baseline hemoglobin \<12.0 g/dL for males or \<11.0 g/dL for females; prothrombin time (PT) greater than the ULN; or aPTT greater than the ULN.
• •13. Clinically significant liver dysfunction (e.g., as evidenced by elevated liver function tests).
• •14. Clinically significant renal dysfunction (e.g., estimated glomerular filtration rate \<60 mL/min or serum creatinine \>1.5 mg/dL).
• •15. History of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator.
• •16. Positive findings on urine drug screen.
• •17. Positive findings for human immunodeficiency virus, hepatitis B, and/or hepatitis C at Screening.
• •18. Pregnant or lactating.
• •19. Acute illness within 1 week of CRU admission.
• •20. A history of alcohol abuse in the past year relative to CRU admission.
• •21. Donated plasma within 7 days of study drug administration.
• •22. Donated 1 or more pints of blood (or equivalent blood loss) within 6 weeks prior to study drug administration.
• •23. Use of an investigational drug within 30 days prior to CRU admission or prior REG1 Anticoagulation System exposure.