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

Study Overview
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Brief Summary
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Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

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

Official Title
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Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo

Conditions
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Healthy Adults

Intervention / Treatment
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* Combination Product: Drug:OP0201
* Combination Product: Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria includes but is not limited to: Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening. No history or presence of significant medical condition or a clinically significant abnormal finding, as determined by the investigator. Negative urine pregnancy test at screening and baseline for females of childbearing potential Agree to refrain from water immersion of the ears from the time of signed informed consent to the end of trial Physiologic tympanogram type A (normal) or type C at screening visit Exclusion Criteria includes but is not limited to: Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to screening visit Positive urine drug screen at screening visit Upper respiratory tract infection currently or within 6 weeks prior to screening visit Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening visit Claustrophobia that is sufficient to prevent them tolerating assessments while in a hypobaric/hyperbaric atmospheric pressure chamber Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit Clinically significant findings on ear nose and throat exam Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit Current diagnosis of sleep apnea Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may interfere with ET function Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug: OP0201<br>20 mg dose one time, followed by a washout and then a 0 mg dose one time, cross over design | Combination Product: Drug:OP0201<br>* Drug: OP0201<br>|
| Placebo Comparator: Drug: Placebo<br>0 mg dose one time, followed by a washout and then a 20 mg dose one time, cross over design | Combination Product: Drug: Placebo<br>* Drug: Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Evaluation of Adverse Events) | All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis. | Days 1-9 |