Healthy Adults
Conditions
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
Interventions
COMBINATION_PRODUCTDrug:OP0201
Drug: OP0201
COMBINATION_PRODUCTDrug: Placebo
Drug: Placebo
Sponsors
Novus Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Evaluation of Adverse Events) | Days 1-9 | All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug: OP0201 First, Then Placebo Participants first received 20mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design
Drug:OP0201: Drug: OP0201 | 9 |
| Drug: Placebo First, Then OP0201 Participants first received 0 mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design
Drug: Placebo: Drug: Placebo | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Drug: OP0201 First, Then Placebo | Total | Drug: Placebo First, Then OP0201 |
|---|---|---|---|
| Age, Continuous | 27.0 years STANDARD_DEVIATION 5.7 | 25.8 years STANDARD_DEVIATION 5 | 24.5 years STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Region of Enrollment Germany | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 12 / 17 | 14 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
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.
Time frame: Days 1-9
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug: OP0201 | Safety (Evaluation of Adverse Events) | 17 Participants |
| Drug: Placebo | Safety (Evaluation of Adverse Events) | 17 Participants |