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

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 body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
• •Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (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.