Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Inclusion Criteria includes but is not limited to:

1. Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.
2. No history or presence of significant medical condition or a clinically significant abnormal finding, as determined by the investigator.
3. Negative urine pregnancy test at screening and baseline for females of childbearing potential
4. Agree to refrain from water immersion of the ears from the time of signed informed consent to the end of trial
5. Physiologic tympanogram type A (normal) or type C at screening visit

Exclusion Criteria includes but is not limited to:

1. Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to screening visit
2. Positive urine drug screen at screening visit
3. Upper respiratory tract infection currently or within 6 weeks prior to screening visit
4. Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening visit
5. Claustrophobia that is sufficient to prevent them tolerating assessments while in a hypobaric/hyperbaric atmospheric pressure chamber
6. Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit
7. Clinically significant findings on ear nose and throat exam
8. Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit
9. Current diagnosis of sleep apnea
10. Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may interfere with ET function
11. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

9 days

The safety population included all randomized participants who received at least one spray of study treatment in either nare.