MAD Study Evaluating the Safety, Tolerability, and PK Effects of N91115 in Healthy Subjects

This Phase 1 study in healthy subjects is being conducted to assess the safety,
tolerability, and pharmacokinetics of N91115.

Inclusion Criteria:

- Subject voluntarily agrees to participate in this study and signs an Institutional
Review Board (IRB)-approved informed consent prior to performing any of the screening
procedures and in the opinion of the PI complies with all the requirements of the
study.

- Subject is healthy, determined at the screening medical evaluation (including but not
limited to medical history, physical examination and clinical laboratory
evaluations).

- Subject is Caucasian.

- Female subject must be of non-childbearing potential (surgically sterile
[hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle
stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy
(HRT) are eligible to enroll.

- Male subject must agree to use condoms and refrain from sperm donation from Day 1
until 30 days post last dose or have documentation of vasectomy.

- Subject has a body weight > 50 kg and BMI between 19.5 and 32 kg/m2, inclusive, at
screening.

- Subject has no clinically significant abnormal findings related to their systolic or
diastolic BP, per the investigator's judgment, at screening or Day 1.

- Subject has no clinically significant abnormal findings in 12 lead ECG, per the
investigator's judgment, at screening.

Exclusion Criteria:

- Subject has clinically significant history or evidence of cardiovascular,
respiratory, hepatic, renal, gastrointestinal, endocrine, neurological,
immunological, or psychiatric disorder(s) as determined by the investigator or
designee.

- Subject has clinically significant abnormalities on a 12 lead ECG done at screening

- Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at
screening

- Subject has any disorder that would interfere with the absorption, distribution,
metabolism, or excretion of drugs.

- Subject has any concurrent disease or condition that, in the opinion of the
investigator, would make the subject unsuitable for participation in the clinical
study.

- Subject is unlikely to comply with the protocol requirements, instructions, and study
related restrictions; e.g., uncooperative attitude, unavailable for follow-up call,
and/or improbability of completing the clinical study.