Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Healthy Adult Volunteers

• Registration Number: NCT03748758
• Lead Sponsor: Novus Therapeutics, Inc

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of two dose levels of OP0201 and placebo, when administered intranasally in healthy adults subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Study Start: 2018-11-27
• Primary Completion: 2019-03-20
• Study Completion: 2019-03-20
• Results First Submitted: 2020-01-30
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Results First Posted: 2020-02-25
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With of Adverse Events	21 Days

Secondary Outcome Measures

Name	Time	Method
Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint	Day 1 and Day 14	This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day
Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint	Day 1 and Day 14	This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day
Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint	Day 1 and Day 14	This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day
Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint	Day 1 and Day 14	This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day

Trial Locations

Locations (1)

Vince and Associates; 🇺🇸 Overland Park, Kansas, United States