Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)

Exclusion Criteria

• •1. History of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (e.g., history of head trauma or concussion, previous alcohol abuse, substance abuse)
• •2. Any concurrent disease or condition that, in the opinion of the Investigator, would make the volunteer unsuitable for participation in the clinical study
• •3. History of alcohol and/or illicit drug abuse within two years of entry
• •4. Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, anxiety or delusions)
• •5. History of cerebrovascular events or non-vasovagal related loss of consciousness
• •6. History of cardiac arrhythmias, ischemic heart disease or cerebrovascular disease
• •7. Hepatic impairment as defined by \>1.3 times the upper limit of normal ranges of serum liver enzymes
• •8. Renal impairment as defined by abnormal ranges of serum creatinine.
• •9. Presence of clinically significant orthostatic hypotension (fall in systolic blood pressure of \>20 mmHg or fall diastolic blood pressure of \> 10 mmHg; and increase in heart rate by \> 20 beats per minute \[bpm\])
• •10. Corrected QT interval (QTc) values of \> 450 ms for males and \> 470 ms for females.
• •11. Volunteers with abnormally low serum B12, folate or abnormal thyroid function tests
• •12. Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
• •13. Positive urine test for alcohol or drugs
• •14. Suicidal ideation
• •15. Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test
• •16. Clinically significant deviation from normal in physical examination, vital signs or clinical laboratory tests
• •17. Volunteer is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study