Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis

Inclusion Criteria

• End Stage Renal Disease (ESRD) maintained on stable outpatient hemodialysis regimen, using an established (> 3 months) and normally functioning, regular flow, uninfected mature AV fistula (or AV graft) and skin consistent with standard chronic hemodialysis access injuries, and hemodialysis stability defined as Kt/V ≥ 1.2 within 3 months prior to screening at a healthcare center for > 3 months from screening.
• On hemodialysis regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well maintained AV fistula (or AV graft), expected and plan to continue this throughout and for at least 3 months beyond the study.
• Is capable of understanding the written informed consent, provides signed and witnessed written informed consent and agrees to comply with protocol requirements and study related procedures.
• Willing to be confined to the clinical research unit for the duration of the study, able to comply with all study-related requirements, and able to adhere to study restrictions and visit schedules.
• Male or female, between 18 and 80 years of age (inclusive) at the time of screening.
• Body Mass Index (BMI) of ≥ 18 at the time of screening.
• Considered by the principle investigator (PI) to be clinically stable with respect to underlying ESRD, based on the medical evaluation that includes medical and surgical history, and a complete physical examination including vital sign measurements, electrocardiograms (ECGs), and clinical laboratory and coagulation test results at screening. Repeat assessments are permitted for any laboratory, coagulation, ECG, or vital sign parameter required for enrollment.
• Female patients must be of non-childbearing potential and must have undergone one of the following sterilization procedures at least 6 months prior to dosing:
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy;

or be postmenopausal with amenorrhea for at least 1 year prior to dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status as per PI or designee judgment.

• Male patients must either be sterile (vasectomy with history of a negative sperm count following the procedure); practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable); use a male condom with any sexual activity; or agree to use a birth control method considered to be appropriate by the Investigator from the time of dosing until 90 days after study drug administration. Male patients must agree not to donate sperm for a period of 90 days after study drug administration.

Exclusion Criteria

• Documented history of acute vasoocclusive thrombotic event (acute coronary syndrome, stroke or transient ischemic attack, venous thromboembolic event), or vascular access fistula or AV graft failure in the past 3 months.
• With the exception of unfractionated heparin during HD that is allowed until study check-in, concomitant or prior use of anticoagulant/antiplatelet agents (e.g., low molecular weight heparins, warfarin, apixaban, bivalirudin, ticagrelor, edoxaban, dabigatran, rivaroxaban, clopidogrel, prasugrel, ticlopidine, eptifibatide, tirofiban, dipyridamole, diclofenac, and all other non steroidal antiinflammatory drugs) that may affect hemostasis for 2 weeks prior to check in on Day -8 and throughout the study.
• Any clinically significant (CS) concomitant disease or condition (including treatment for such conditions) that, in the opinion of the PI, could either interfere with the study drug, compromise interpretation of study data, or pose an unacceptable risk to the patient.
• Any other CS abnormalities in laboratory test results at screening or Day
• 8 check-in that would, in the opinion of the PI, increase the patient's risk of participation, jeopardize complete participation in the study, or compromise interpr