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

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo

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

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Combination product: Drug:OP0201; Combination product: Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Cologne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug: OP0201; 20 mg dose one time, followed by a washout and then a 0 mg dose one time, cross over design	Combination product: Drug:OP0201; Drug: OP0201
Placebo Comparator: Drug: Placebo; 0 mg dose one time, followed by a washout and then a 20 mg dose one time, cross over design	Combination product: Drug: Placebo; Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novus Therapeutics, Inc

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Actual): March 7, 2019
• Study Completion (Actual): March 7, 2019

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OP0201-C-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes