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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Adult Volunteers

Intervention / Treatment
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* Combination Product: Drug: OP0201
* Combination Product: Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria includes but is not limited to: Body mass index of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at Screening. 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. Female subjects must agree to use an acceptable method of contraception (for pregnancy considerations and contraceptive requirements). Female subjects who are of childbearing potential must have a negative urine pregnancy test result at Screening and Day -1 prior to randomization. Male subjects must agree to use contraception 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. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee. Exclusion Criteria includes but is not limited to: History or presence of significant medical condition or a clinically significant abnormal finding, as determined by the Investigator. Presence of a clinically significant abnormal olfactory test finding at Screening defined as a total UPSIT score <35 (for females) and <34 (for males). Clinically significant ear disorder/disease currently or within 6 weeks prior to Screening. History of tympanostomy tubes in one or both ears within 1 year prior to Screening. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to Screening. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to Screening. Clinically relevant blockage of one or both nasal passages, in the Investigator's opinion. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug: OP0201 (30 mg)<br>Cohort A- 30 mg per day X 14 days | Combination Product: Drug: OP0201<br>* Drug OP0201<br>|
| Placebo Comparator: Drug: Placebo<br>Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days | Combination Product: Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Drug: OP0201 (60 mg)<br>Cohort B-60 mg per day X 14 days | Combination Product: Drug: OP0201<br>* Drug OP0201<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With of Adverse Events |  | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |