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

Phase 1

Completed

• Conditions: Healthy Adults

• Registration Number: NCT03828149
• Lead Sponsor: Novus Therapeutics, Inc

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

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Study Start: 2019-02-08
• Primary Completion: 2019-03-07
• Study Completion: 2019-03-07
• Status Verified: 2019-10
• Results First Submitted: 2019-10-30
• Results First Submitted QC: 2019-12-06
• Last Update Submitted: 2019-12-06
• Results First Posted: 2019-12-30
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cologne University Hospital; 🇩🇪 Cologne, Germany