Phase 1 Study of NPT200-11 in Healthy Subjects

Inclusion Criteria:

Subjects who meet all of the following inclusion criteria will be eligible to participate
in this study:

1. informed of, and willing and able to comply with, all of the protocol requirements
and the investigational nature of the study, and have signed an informed consent form
in accordance with institutional and regulatory guidelines;

2. male or female adults between 18 and 55 years of age, inclusive;

3. female subjects must be post-menopausal for at least 2 years or surgically sterile
(hysterectomy, bilateral oophorectomy, tubal ligation);

4. male subjects must be willing to use an adequate barrier method of contraception for
the duration of the study and for 90 days after dosing and no sperm donations for the
duration of the study and for 90 days after dosing. Male subjects who are surgically
sterile need not employ a method of contraception;

5. non-smokers for at least six months;

6. BMI = 18 - 30 kg/m2, inclusive;

7. in good health, in the judgment of the Principal Investigator, as determined by:

- medical history indicative of no serious or severe chronic conditions requiring
frequent medical intervention or continual pharmacologic management, and no
medical or social conditions that would potentially interfere with the subject's
ability to comply with the study visit schedule or the study assessments;

- no clinically significant abnormalities in body temperature, heart rate,
respiratory rate, blood pressure;

- no clinically significant abnormalities in the 12-lead electrocardiogram (ECG);

- no clinically significant abnormalities in clinical chemistry (ALT, AST, total
bilirubin must be at or below the upper limit of normal and eGFR must be above
90 mL/min), hematology (hemoglobin ≥ 12.0 g/dL), coagulation and urinalysis; lab
tests may be repeated, if necessary (details are provided in the attached flow
chart of study assessments).

8. negative results on the following screening laboratory tests: urine drug screen,
urine alcohol screen, serum pregnancy test, hepatitis B surface antigen, hepatitis C
antibody, and human immunodeficiency virus antibody.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria will NOT be eligible to
participate in this study:

- females of child bearing potential;

- history of a significant medical condition that may interfere with absorption,
distribution or elimination of NPT200-11, or with the clinical and laboratory safety
assessments in this study;

- history of drug hypersensitivity and disorders affecting respiratory function (e.g.,
COPD, asthma) and cardiac disorders predisposing to cardiac adverse events;

- history of or current alcohol abuse and/or other drug addiction < 2 years prior to
screening, or a positive urine drug or alcohol screen (e.g., amphetamines,
barbiturates, benzodiazepines, opiates, cannabinoids, alcohol and cocaine);

- positive for HBVsAg, HCV Ab, HIV Ab;

- 12 lead ECG showing the following: having a corrected QTc interval > 450 msec or <320
msec (Fridericia's correction);

- sustained sitting systolic blood pressure > 140 or < 90 mm Hg or sitting diastolic
blood pressure > 90 or < 50 mm Hg at Screening or Day -1 (sentinel pair) or Day 1
(remaining 6 subjects in the cohort), the average of the 2 assessments of BP taken at
each visit will be used to exclude a subject;

- resting pulse rate at screening of > 100 or < 45;

- donated or lost > 500 mL of blood < 56 days prior to enrollment into this study;

- plasma donation within 7 days prior to enrollment into this study;

- active infection or febrile illness < 14 days prior to the first dose of study
medication;

- use of prescription or over-the-counter medications or herbal supplements ≤ 14 days
prior to dosing and until completion of follow-up visit on Day 7;

- have participated in other clinical studies of a new chemical entity within 30 days
prior to admission to the CRU.