Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers

Exclusion criteria

• . Psychosis and bipolar disorder: Any lifetime history of psychosis or bipolar disorder.
• . Current Psychiatric Disorder: Current or recent (within the last year) DSM-5 diagnosis of any other psychiatric disorder that would make study participation unsafe, including but not limited to depressive disorders, trauma- or stress related disorders, and anxiety disorders that in the opinion of the investigator would make study participation unsafe.
• . Substance Use Disorder: Current DSM-5 diagnosis (any severity) of an alcohol or drug use disorder, or use of illicit/non-prescribed substances within the last 12 months.
• . Suicidality: Current or recent suicidal or homicidal ideation (C-SSRS "yes" answers on any questions) or a history of suicide attempt within the past 12 months.
• . Neurological Disorders: History of neurological disorders including epilepsy or a family history of epilepsy, intractable/complicated migraine syndromes, cluster headache syndrome, extrapyramidal/pyramidal disorders, cerebrovascular, or degenerative disorders.
• . Seizure History: Any lifetime history of seizure.
• . Traumatic Brain Injury (TBI): Lifetime history of brain injury with loss of consciousness \> 30 minutes, Past-year brain injury with loss of consciousness \< 30 minutes.
• . Cardiovascular Conditions: History of heart failure, cardiomyopathy, sick sinus syndrome, second or third-degree AV block, myocardial infarction, pulmonary congestion, symptomatic/significant cardiac arrhythmia, or clinically significant abnormal conduction on baseline ECG.