Phase 2 Study of Apixaban Reversal by Ciraparantag as Measured by WBCT

Inclusion Criteria:

1. Adults age 50 to 75 years, inclusive

2. Laboratory tests (chemistry, hematology and coagulation assessments) and urinalysis
performed during screening up to 36 days prior to administration of study treatment
deemed not clinically significant by the principal investigator.

3. No clinically significant findings on 12-lead electrocardiogram (ECG) performed during
screening

4. Body mass index (BMI) 18 to ≤ 32 kg/m2, inclusive

5. Male subjects agree to use appropriate contraception (i.e., latex condom with
spermicide) in addition to their partner using an acceptable form of contraception
(e.g., diaphragm, cervical cap, intrauterine device, hormonal contraceptives, surgical
sterilization or post-menopausal), when engaging in sexual activity during the course
of the study. Moreover, male subjects should not donate sperm or attempt to impregnate
a partner during the course of the study and for a period of 12 weeks following
discharge from the study.

6. Female subjects must have a negative urine pregnancy test at screening AND: be
surgically sterile (with documentation of hysterectomy, bilateral oophorectomy,
bilateral salpingectomy, bilateral tubal ligation/tubal occlusion) OR post-menopausal
(no menstruation for a minimum of 12 months and confirmed by follicle stimulating
hormone [FSH] of ≥ 40 mIU/ml) OR, if of child-bearing potential, must be using an
acceptable method of contraception such as an IUD, implant or contraceptive injection,
or two forms of the following (e.g., diaphragm, cervical cap, oral, patch or vaginal
hormonal contraceptive, condom, spermicide, or sponge) for the last three months, OR
in a monogamous relation with a male partner who has undergone a documented vasectomy
a minimum of 6 months prior to study commencement. All females must agree to continue
to use their method of birth control for the duration of the study and for a minimum
of one complete menstrual cycle or 28 days following discharge from the study
Ciraparantag Perosphere Inc. Clinical Trial Protocol: PER977-02-011 9 August 2017
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7. Subjects who have participated in a prior study of ciraparantag must have been
discharged from the study a minimum of 1 month prior to the planned treatment.

8. Subjects must understand and agree to comply with the requirements of the study and
they must be willing to sign the informed consent form indicating voluntary consent to
participate in the study prior to initiation of screening or study-related activities
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Exclusion Criteria:

1. History or current evidence of clinically significant cardiac, hepatic, renal,
pulmonary, endocrine, neurologic, infectious, gastrointestinal (including gallbladder
disease or surgery), hematologic, or oncologic disease as determined by screening
history, physical examination, laboratory test results or 12-lead ECG assessment.
History or current evidence of liver function tests greater than 50% of the upper
limit of normal (ULN) or renal function tests (serum creatinine) greater than 1.5
mg/dl and based on PI discretion. History or current evidence of QTc (QTcF) greater
than normal (450 msec for males or 470 msec for females).

2. History of unexplained syncope

3. History of major bleeding, trauma, or surgical procedure of any type,

4. Vaginal delivery within six months prior to screening

5. History of peptic ulcer, gastrointestinal bleeding (including hematemesis, melena,
rectal bleeding) within one year prior to screening

6. Long standing history of bleeding episodes such as epistaxis, bruising or gingival
bleeding or if not long standing, within 1 month prior to screening

7. Personal or family history of clotting disorder or abnormality, excessive bleeding,
joint hematoma, thrombovascular disease or any hematologic disorder involving
platelets or clotting abnormalities or any condition requiring treatment with
transfusions, or history of thrombocytopenia

8. Females with a history of dysfunctional uterine bleeding who have not undergone
hysterectomy, including history of menorrhagia (heavy menstrual bleeding),
menometrorrhagia or polymenorrhea

9. Smokers or use of tobacco and/or nicotine containing products within 3 months prior to
dosing as determined by the subject's verbal history

10. Pregnant or breast-feeding

11. Males with a history of hormone therapy within 3 months prior to screening

12. Taking any type of chronic medication (including vitamin, nutritional and herbal
supplements) for more than 14 consecutive days within the 4 weeks prior to study entry
(use of hormonal contraceptives is acceptable except for oral contraceptives)

13. Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus
antibody (HCV-Ab), or Hepatitis B surface antigen (HBsAg)

14. Donation of blood or blood products within 56 days prior to screening

15. Participation in any study with an investigational compound or device within 30 days
prior to signing informed consent

16. Active drug or alcohol dependence within the prior 12 months or any condition that, in
the opinion of the Investigator, would interfere with adherence to study protocol

17. Allergic to apixaban