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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06147921




Registration number
NCT06147921
Ethics application status
Date submitted
2/11/2023
Date registered
28/11/2023
Date last updated
28/11/2023

Titles & IDs
Public title
Phase 1, SAD/MAD of Verasone™ Administered by Sinonasal Irrigation in Healthy Participants
Scientific title
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Verasone™ Administered by Sinonasal Irrigation in Healthy Participants
Secondary ID [1] 0 0
VER-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Verasone

Experimental: SAD Dose Level 1 - Sinonasal irrigation of lowest dose Verasone vs placebo

Experimental: SAD Dose Level 2 - Sinonasal irrigation of second lowest dose Verasone vs placebo

Experimental: SAD Dose Level 3 - Sinonasal irrigation of third lowest dose Verasone vs placebo

Experimental: SAD Dose Level 4 - Sinonasal irrigation of highest dose Verasone vs placebo

Active comparator: Crossover Component - Each active component from the highest well tolerated dose of Verasone will be administered via sinonasal irrigation alone in a within subject crossover to compare plasma drug levels to that seen when dosed with Verasone.

Experimental: MAD Dose Level 1 - The next to highest well tolerated dose of Verasone in the SAD study will be compared to one of the active components in Verasone and to placebo in a 5 day b.i.d. dosing regimen

Experimental: MAD Dose Level 2 - The highest well tolerated of Verasone in the SAD study will be compared to one of the active components in Verasone and to placebo in a 5 day b.i.d. dosing regimen.


Treatment: Drugs: Verasone
Administered by sinonasal irrigation.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Single Ascending Dose (SAD)
Timepoint [1] 0 0
1 week
Primary outcome [2] 0 0
Part B: Single Dose Component Crossover
Timepoint [2] 0 0
3 weeks
Primary outcome [3] 0 0
Part C: Multiple Ascending Dose (MAD)
Timepoint [3] 0 0
2 weeks
Secondary outcome [1] 0 0
To assess the volume of retained fluid and amount of mucosal absorption in the sinonasal system immediately following single dose Verasone vs placebo administered by sinonasal irrigation in healthy participants.
Timepoint [1] 0 0
30 min

Eligibility
Key inclusion criteria
Main

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

Additional inclusion criteria for Part B:
4. 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.
5. Participant did not experience local toxicity AEs or anterior rhinoscopy findings during Part A.

Main
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of allergy, hypersensitivity, or contraindication to corticosteroids or calcium channel blockers.
2. History of severe allergic or anaphylactic reactions or sensitivity to the IP or its constituents.
3. Any clinical obstruction of the nasal cavities that would reduce access for topical irrigations
4. Nasal candidiasis, nasal mucosal ulceration, thinning or eroded nasal septum, or nasal septum perforation.
5. 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.
6. Ongoing nasal congestion at Screening or Day -1 (Nasal Congestion Score > 0).
7. Inability to have anterior rhinoscopy nasal examination (Parts A and B only) or endoscopic nasal cavity examination (Part C only).
8. More than 1 episode of epistaxis.
9. History of or planned sinus or intranasal surgery.
10. Use of immunomodulating drugs, except glucocorticoids, within 90 days prior to Screening or intent to use these drugs during the study.
11. Exposure to any glucocorticoid treatment via any route (nasal, topical, inhaled, oral, intravenous, etc.) within 1 month prior to Screening.
12. Received biologic therapy/systemic immunosuppressant to treat inflammatory or autoimmune disease.
13. Oral steroid-dependent or monoclonal antibody-dependent (eg, omalizumab, mepolizumab, dupilumab) condition.
14. Use of potent cytochrome P450 3A4 (CYP3A4) inhibitor(s) or inducer(s) within 14 days prior to Screening.
15. Known history of HPA axial dysfunction, or previous pituitary or adrenal surgery.
16. History or diagnosis of eustachian tube dysfunction, recurrent otitis media.
17. Any history or ongoing clinically significant cardiac disease.
18. Abnormal vital signs or ECG findings.
19. History or current diagnosis of any form of glaucoma or ocular hypertension.
20. A history of cancer, HIV, or other immunodeficiency, or immune system-mediated disorder.
21. History of insulin-dependent diabetes mellitus.
22. History of any clinically significant hepatic or renal disease.
23. Clinically significant abnormal laboratory parameters at Screening.
24. Any underlying physical or psychological medical condition.
25. A recent clinically significant history of drug or alcohol use, abuse, or dependence.
26. Positive screen for drugs of abuse or alcohol at Screening or Day -1.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/12/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Diceros Therapeutics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Diceros Therapeutics Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of Verasone versus placebo in healthy normal participants and will evaluate the PK profiles of the Verasone active components administered individually vs in combination.
Trial website
https://clinicaltrials.gov/study/NCT06147921
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Warren C Stern, PhD
Address 0 0
Country 0 0
Phone 0 0
+1 617 688 1345
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06147921