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

Novus Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Combination Product: Drug: Placebo; Combination Product: Drug:OP0201

Study type: Interventional

Funder types: Industry

Identifiers

NCT03828149

OP0201-C-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 17 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 2 patient groups, including a placebo group

Drug: OP0201

Active Comparator group

Description:

20 mg dose one time, followed by a washout and then a 0 mg dose one time, cross over design

Treatment:

Combination Product: Drug:OP0201

Drug: Placebo

Placebo Comparator group

Description:

0 mg dose one time, followed by a washout and then a 20 mg dose one time, cross over design

Treatment:

Combination Product: Drug: Placebo