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

NCT03828149 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: OP0201-C-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Drug: OP0201

ACTIVE COMPARATOR

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: Placebo

PLACEBO COMPARATOR

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

Combination Product: Drug: Placebo

Interventions

Drug:OP0201 COMBINATION_PRODUCT

Drug: OP0201

Drug: OP0201

Drug: Placebo COMBINATION_PRODUCT

Drug: Placebo

Drug: Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novus Therapeutics, Inc: lead

Study Sites (1)

Cologne University Hospital

Cologne, 50937, Germany

Location

Related Links

• Related Info

Results Point of Contact

• Title: Clinical Director
• Organization: Novus Therapeutics

study001@novustherapeutics.com

949-679-1110

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 4, 2019
• Study Start: February 8, 2019
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: December 30, 2019
• Results First Posted: December 30, 2019

Record last verified: 2019-10

Locations

DE (1)