Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors

Inclusion Criteria:

- Male and female subjects between the ages of 18 to 75 with documented vascular
disease (peripheral vascular disease, carotid artery disease or coronary artery
disease) or 2 or more coronary artery risk factors.

- Women of childbearing potential must have a negative pregnancy test prior to
enrollment and immediately before drug administration and agree to use two methods of
effective barrier contraception, or a hormonal contraceptive to prevent pregnancy
throughout the study.

- The subject is able to read and give written informed consent and has signed and
dated an informed consent document and authorization permitting release of personal
health information approved by the Investigator's Institutional Review Board (IRB).

Exclusion Criteria:

- The subject has participated in an investigational drug study within the last 30
days.

- The subject has a medical or surgical condition that may impair drug absorption or
metabolism.

- Anticoagulants, P2Y12 inhibitors, nonsteroidal antiinflammatory drugs (no more than
three times a week) or any other drug that the investigator deems to have potential
interaction with platelets or PAR-1 receptor inhibition are prohibited from 2 weeks
prior to study drug dosing through 2 weeks post dosing. Aspirin is allowed.

- The subject has previous history of anaphylaxis to drugs or any environmental stimuli
including foods or hymenoptera (e.g., ants, bees, wasps) stings.

- Asthma requiring bronchodilator/inhaler therapy.

- Currently smoking ≥2 pack/day.

- Herbal supplements (i.e., Fish Oil/Omega-3, St. John's Wart, Ginseng, Garlic, Ginkgo,
Saw Palmetto, Echinacea, Yohimbine, Licorice, and Black Cohosh) are prohibited from 1
week prior to dosing through 24 hours post dosing.

- Prior history or clinical suspicion of cerebral vascular malformations, intracranial
tumor, transient ischemic attack, stroke, gastric ulcers and any form of bleeding
disorder.

- Prior history of myocardial infarction within the last 3 months or unstable angina.

- Thrombocytopenia defined as a platelet count of <130,000/mm3 or low hematocrit
defined as <30%.

- Renal function: serum creatinine >1.5 x ULN. However, subjects with an estimated
creatinine clearance eGFR ≥60 mL/min, calculated using the Cockcroft-Gault formula,
are eligible.

- Liver enzymes ≥ 3 x upper limit of normal.

- Alcohol consumption within 48 hrs prior to dosing, and for the duration of the
in-house study period.

- Evidence of history of substance or alcohol abuse at screening, including positive
urine test results for drugs or positive breath test for alcohol.

- Uncontrolled hypertension or hypotension defined as a sustained supine systolic
pressure >160 mmHg or <100 mmHg; or a diastolic pressure >90 mmHg or < 50 mmHg.

- International normalized ratio (INR) >1.5

- Poor venous access (i.e., insufficient for intravenous drug delivery).

- History of hepatitis or HIV.

- The subject has undergone an invasive surgical procedure within the last 3 months, is
anticipating one during the course of their study participation or is planning to
have one within 1 month post dosing with the study drug.

- The subject has any condition which could interfere with or for which the treatment
might interfere with the conduct of the study, or which would, in the opinion of the
Investigator increase the risk of the subject's participation in the study. This
would include, but is not limited to alcoholism, drug dependency or abuse,
psychiatric disease, epilepsy or any unexplained blackouts, previous hypersensitivity
to drugs, and severe asthma.