Phase 1, SAD/MAD of Verasone™ Administered by Sinonasal Irrigation in Healthy Participants

Main Inclusion Criteria:

• In good general health based on medical history, physical examination, vital signs, ECG, laboratory parameters, and other relevant tests
• Able to perform study procedures, including self-administration of sinonasal irrigation of 60 mL in each nostril
• Able and willing to attend the necessary visits to the study site.

Additional inclusion criteria for Part B:

• Participant met all eligibility criteria for Part A, completed Part A with no major protocol deviations, and all Part A safety and PK assessments were completed, in the opinion of the PI.
• Participant did not experience local toxicity AEs or anterior rhinoscopy findings during Part A.

Main Exclusion Criteria:

• History of allergy, hypersensitivity, or contraindication to corticosteroids or calcium channel blockers.
• History of severe allergic or anaphylactic reactions or sensitivity to the IP or its constituents.
• Any clinical obstruction of the nasal cavities that would reduce access for topical irrigations
• Nasal candidiasis, nasal mucosal ulceration, thinning or eroded nasal septum, or nasal septum perforation.
• History or clinical evidence of CRS, fungal rhinosinusitis, or rhinitis medicamentosa at any time, or any active allergic rhinitis, acute sinusitis, or upper respiratory infection within 4 weeks prior to Screening.
• Ongoing nasal congestion at Screening or Day -1 (Nasal Congestion Score > 0).
• Inability to have anterior rhinoscopy nasal examination (Parts A and B only) or endoscopic nasal cavity examination (Part C only).
• More than 1 episode of epistaxis.
• History of or planned sinus or intranasal surgery.
• Use of immunomodulating drugs, except glucocorticoids, within 90 days prior to Screening or intent to use these drugs during the study.
• Exposure to any glucocorticoid treatment via any route (nasal, topical, inhaled, oral, intravenous, etc.) within 1 month prior to Screening.
• Received biologic therapy/systemic immunosuppressant to treat inflammatory or autoimmune disease.
• Oral steroid-dependent or monoclonal antibody-dependent (eg, omalizumab, mepolizumab, dupilumab) condition.
• Use of potent cytochrome P450 3A4 (CYP3A4) inhibitor(s) or inducer(s) within 14 days prior to Screening.
• Known history of HPA axial dysfunction, or previous pituitary or adrenal surgery.
• History or diagnosis of eustachian tube dysfunction, recurrent otitis media.
• Any history or ongoing clinically significant cardiac disease.
• Abnormal vital signs or ECG findings.
• History or current diagnosis of any form of glaucoma or ocular hypertension.
• A history of cancer, HIV, or other immunodeficiency, or immune system-mediated disorder.
• History of insulin-dependent diabetes mellitus.
• History of any clinically significant hepatic or renal disease.
• Clinically significant abnormal laboratory parameters at Screening.
• Any underlying physical or psychological medical condition.
• A recent clinically significant history of drug or alcohol use, abuse, or dependence.
• Positive screen for drugs of abuse or alcohol at Screening or Day -1.