Criteria

Inclusion Criteria:

Informed of the nature of the study and are able to read, review, agree to, and sign the informed consent document at Screening. Able to comply with all protocol-specified visit schedules and requirements. Healthy male and female subjects 18 to 50 years of age, inclusive, at the time of dosing. Body mass index (BMI) between 22 kg/m2 to 35 kg/m2, inclusive, and weigh at least 110 lbs (50 kg).

4a. Systolic blood pressure ≥110 mmHg (subject in the seated position and legs dangling) also, 5 minutes after moving from the supine to seated position any drop in systolic pressure must be <15 mmHg and any increase in pulse <10 bpm.

5. Judged by the PI to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead ECG, clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the PI and if judged not to be clinically significant, the subject may be considered for study participation.

6. Adequate hepatic, renal, hematologic and clotting function as defined by total bilirubin, AST, ALT, serum creatinine, D-dimer and International normalized ratio (INR) within normal range as determined by the PI and Sponsor Medical Monitor.

7. Female subjects must be one of the following:

naturally postmenopausal (no menses) for >2 years and has a documented FSH level >40 mIU/mL; or

have a documented history of ovarian failure; or

surgically postmenopausal (bilateral oophorectomy or hysterectomy). Female subjects that are surgically postmenopausal must provide documentation of the bilateral oophorectomy or hysterectomy prior to Day 1 dosing to be eligible for participation in the study; or

Women of childbearing potential (FSH ≤40 mIU/mL) must have negative serum hCG at Screening, a negative urine pregnancy test prior to the first study treatment, and must agree to utilize highly effective contraception methods (2 separate forms of contraception, 1 of which must be an effective barrier method, or be non-heterosexually active, or have a vasectomized partner) from Screening throughout the duration of study treatment and for 1 month after the last administration of study treatment. 8. Male subjects who are sexually active must be willing to use effective barrier contraception (e.g., condom with spermicide) during heterosexual intercourse from Screening throughout the duration of study treatment and for 1 month after the last dose of study treatment.

Exclusion Criteria: