Status:
COMPLETED
Phase 1, SAD/MAD of Verasone™ Administered by Sinonasal Irrigation in Healthy Participants
Lead Sponsor:
Diceros Therapeutics
Collaborating Sponsors:
Diceros Therapeutics Australia Pty Ltd
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Verasone™ is an aqueous suspension of the combination of two marketed drugs to be dosed by sinonasal irrigation in the treatment of Chronic Rhinosinusitis (CRS). This Phase 1 first-in-human study will...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06147921
Start Date
December 15 2023
End Date
December 13 2024
Last Update
January 23 2025
Active Locations (1)
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1
Nucleus Network
Melbourne, Victoria, Australia, 3004