Status:
COMPLETED
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Lead Sponsor:
Novus Therapeutics, Inc
Conditions:
Healthy Adults
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Detailed Description
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03828149
Start Date
February 8 2019
End Date
March 7 2019
Last Update
December 30 2019
Active Locations (1)
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1
Cologne University Hospital
Cologne, Germany, 50937