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

Healthy Adult Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748758
• Other study ID #: OP0201-C-002
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Adult Volunteers

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

External Links

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