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

Healthy Adults Clinical Trial

Official title:

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828149
• Other study ID #: OP0201-C-001
• Status: Completed
• Phase: Phase 1
• Start date: February 8, 2019
• Est. completion date: March 7, 2019

Study information

• Verified date: October 2019
• Source: Novus Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Combination Product:
• Drug:OP0201
Drug: OP0201
• Drug: Placebo
Drug: Placebo

Locations

Country	Name	City	State
Germany	Cologne University Hospital	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Novus Therapeutics, Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Days 1-9

External Links

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