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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03748758
Other study ID # OP0201-C-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 27, 2018
Est. completion date March 20, 2019

Study information

Verified date February 2020
Source Novus Therapeutics, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 20, 2019
Est. primary completion date March 20, 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 of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at Screening.

2. Able and willing to follow study instructions (including compliance with daily study treatment administration) and likely to complete all required study visits as assessed by the Investigator's judgement.

3. Female subjects must agree to use an acceptable method of contraception (for pregnancy considerations and contraceptive requirements).

4. Female subjects who are of childbearing potential must have a negative urine pregnancy test result at Screening and Day -1 prior to randomization.

5. Male subjects must agree to use contraception

6. Subjects must agree to refrain from immersing their head fully under water (eg, swimming, diving) from the time of signed informed consent until after the study exit visit.

7. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.

Exclusion Criteria includes but is not limited to:

1. History or presence of significant medical condition or a clinically significant abnormal finding, as determined by the Investigator.

2. Presence of a clinically significant abnormal olfactory test finding at Screening defined as a total UPSIT score <35 (for females) and <34 (for males).

3. Clinically significant ear disorder/disease currently or within 6 weeks prior to Screening.

4. History of tympanostomy tubes in one or both ears within 1 year prior to Screening.

5. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to Screening.

6. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to Screening.

7. Clinically relevant blockage of one or both nasal passages, in the Investigator's opinion.

8. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Vince and Associates Overland Park Kansas

Sponsors (1)

Lead Sponsor Collaborator
Novus Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With of Adverse Events 21 Days
Secondary Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint 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 Day 1 and Day 14
Secondary Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint 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 Day 1 and Day 14
Secondary Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint 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 Day 1 and Day 14
Secondary Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint 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 Day 1 and Day 14
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