NBP in Adult Patients With Acute Ischemic Stroke (AIS)

This is a randomized, double-blind, placebo-controlled, add-on to standard-of-care study with
a primary objective to assess the safety of NBP treatment in patients with mild to moderate
acute ischemic stroke. The secondary objectives include determination of pharmacokinetic (PK)
profile and exploratory evaluation for the efficacy of NBP treatment in stroke patients.

All randomized subjects will also receive standard supportive medical care for treatment of
AIS throughout the study. The overall duration of the study will be approximately 90 days,
including 30 days of treatment and an additional 60 days for follow up assessments. Subjects
will be hospitalized long enough to receive the first four doses of study drug. After
discharge from the hospital, subjects will continue to take study treatment daily through Day
30 and have scheduled assessments completed.

To maintain the blind, all subjects will take 4 softgel capsules BID, which will contain
either 100 mg NBP or matching placebo. The first dose must be taken within 12 hours of the
onset of the AIS defined as the last known normal.

Inclusion Criteria

1. Males or females aged ≥ 18 and ≤ 85 years.

2. Women of childbearing potential (WOCBP) must have a negative urine HCG pregnancy test
at Screening and be practicing a medically acceptable method of contraception with an
annual failure rate of less than 1% until the completion of the trial or 60 days after
discontinuation of study treatment. Women are considered not childbearing if they are
> 1 year postmenopausal or surgically sterile (ie, hysterectomy, bilateral
oophorectomy, or bilateral salpingectomy tubal ligation). If serum bHCG is the
standard of care, then this value can be used to determine eligibility.

3. A clinical diagnosis of mild to moderate cortical or subcortical AIS.

4. Able to swallow the softgel capsules as defined by the investigator.

5. Completes screening procedures such that study treatment is first administered within
24 hours of stroke onset. The stroke onset time will be defined as the last known
normal.

6. If tPA is given as part of standard of care, the first dose of NBP must be
administered no sooner than 4 hours after the end of the tPA infusion.

7. A standard NIHSS score of 4 to 17, inclusive. If patients receive tPA and/or
endovascular treatment (EVT), the NIHSS score must be obtained after the infusion
and/or procedure is completed. If sedation is used for EVT, then the NIHSS score must
be obtained after sedation no longer confounds the assessment. All subjects must meet
a NIHSS consciousness score of 0-1 in order to meet eligibility.

8. Functionally independent, as defined by a Modified Rankin Scale (mRS) score of 0 to 1
before their present illness as determined by the subject or provided by a
representative if the subject is unable to participate at the time of study entry
(determined by retrospective assessment by the Investigator).

9. Capable of understanding the purpose and risk of the study and has signed, in writing,
the ICF. If the subject is not capable of this at the time of enrollment, a legally
authorized representative (LAR) will provide written informed consent in accordance
with all regulations.

10. Ability to comply with study requirements.

Exclusion Criteria:

1. Female subjects who are pregnant, lactating/breast-feeding, or plan to become pregnant
within the next 3 months.

2. Suspected diagnosis of stroke isolated to brainstem or brain areas other than cortical
or subcortical AIS that may have caused the present symptoms, based on the opinion of
the Investigator.

3. Rapidly improving or resolving symptoms, suggesting a possible transient ischemic
attack (TIA) rather than a qualifying stroke.

4. Signs of acute intracranial hemorrhage or symptomatic hemorrhagic transformation of
AIS defined by a 4-point worsening in NIHSS from presentation, or other cause of acute
stroke symptoms (other than early ischemic findings) on cranial imaging at Screening.

5. History of intracranial hemorrhage.

6. Seizure at onset of stroke.

7. A previous clinical diagnosis of stroke within 6 months of current AIS. A previously
undiagnosed stroke evidenced on screening CT or MRI may be enrolled provided it does
not affect neurological and functional assessments based on the opinion of the
Investigator.

8. Uncontrolled severe hypertension defined as a systolic blood pressure (SBP) ≥ 220 mm
Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg.

9. Treatment with intensive antihypertensive therapy within 4 hours of randomization.

10. SBP < 100 mm Hg, temperature > 38.0º C, or heart rate < 40 beats/minute or > 120
beats/minute at Screening or prior to randomization.

11. A glucose level of < 50 mg/dL at Screening.

12. An international normalized ratio (INR) ≥ 1.5 if not being treated with anticoagulant
therapy, or an INR ≥ 3.5 if being treated with an acceptable anticoagulant therapy.

13. A serum ALT or AST level > 1.5 × ULN, or bilirubin > 1.5 ULN (except in setting of
known Gilbert's disease) at Screening.

14. Clinically significant renal dysfunction (including serum creatinine level > 2.0 mg/dL
or 177 µmol/L) at Screening.

15. A hemoglobin level < 10 g/dL at Screening.

16. Current or within the last 6 months prior to Screening, New York Heart Association
Class III/IV heart failure, severe uncorrected valve disease, known or suspected
infective/vegetative endocarditis, ventricular tachycardia, or torsade de pointes.

17. Corrected QTcF (Fridericia) > 450 ms for male subjects or > 470 ms for female subjects
(average of 3 ECG tracings) prior to randomization.

18. Current diagnosis of cancer or is being treated or has received any treatments for
cancer within the last 5 years except basal cell carcinoma or curatively resected
squamous cell carcinoma.

19. Known life expectancy < 6 months (for any reason).

20. Known allergy or hypersensitivity to celery or soybeans.

21. Received treatment with any other investigational drug within 30 days before Baseline,
was previously treated with NBP, is currently taking celery seed extract, or is
currently participating in another clinical study.

22. Known or suspected history of alcohol or drug dependence within the past 6 months, or
is known to have abused alcohol (eg, been intoxicated) within the last 24 hours.

23. Known history of hepatitis B, hepatitis C, HIV, or TB.

24. Any other reasons that, in the opinion of the investigator, make the subject
unsuitable for enrollment.