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

Inclusion criteria

• An Institutional Review Board (IRB)-approved informed consent was signed and dated prior to any study-related activities.
• Subject was between the ages of 18 and 45 years, inclusive.
• Subject was a female with a negative urine or serum pregnancy test or postmenopausal for at least 1 year prior to randomization.
• Subject had a body mass index (BMI) between 18 kg/m2 and 32 kg/m2 (weight/[height]2) and was ≥50 kg and ≤120 kg total body weight.
• Subject had normal (or abnormal and clinically insignificant) laboratory values at Screening.
• Subject was medically normal with no significant abnormal findings at the Screening physical examination.
• Subject had the ability to understand the requirements of the study and a willingness to comply with all study procedures.
• Subject had not consumed and agreed to abstain from taking any dietary supplements or nonprescription drugs
• Subject had not consumed and agreed to abstain from taking any prescription drugs
• Subject had not consumed alcohol-containing beverages for 3 days prior to CRU admission
• Subject had not consumed grapefruit or grapefruit juice within the 14 days prior to CRU admission
• Subject had not used tobacco or nicotine-containing products within 6 months prior to CRU admission

Exclusion criteria

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