Study of AD128 Versus Placebo in Obstructive Sleep Apnea

Exclusion Criteria

• •History of narcolepsy.
• •Clinically significant craniofacial malformation.
• •Clinically significant cardiac disease or hypertension requiring more than 3 medications for control.
• •Clinically significant neurological disorder, including epilepsy/convulsions
• •History of schizophrenia, schizoaffective disorder or bipolar disorder according to - Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease X edition criteria.
• •History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
• •Positive history for abuse of drugs or substance use disorder as defined in DSM-V within 12 months prior to Screening Visit.
• •A significant illness or infection requiring medical treatment in the past 30 days.
• •Clinically significant cognitive dysfunction.
• •Untreated narrow angle glaucoma.
• •Women who are pregnant or nursing.
• •History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
• •History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
• •History of oxygen therapy.
• •Use of medications from the list of disallowed concomitant medications.
• •Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, or monoamine oxidase inhibitors (MAOI) or linezolid within 14 days of the start of treatment, or concomitant with treatment.
• •Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
• •Central apnea index \> 5/hour on baseline PSG
• •Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
• •Patients considered by the investigator, for any reason, unsuitable candidates to receive AD128 treatment or unable or unlikely to understand or comply with the dosing schedule or study evaluations.