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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147921
• Other study ID #: VER-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 15, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Diceros Therapeutics
• Contact: Warren C Stern, PhD
• Phone: +1 617 688 1345
• Email: wstern[@]dicerostherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Main Inclusion Criteria:

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 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Verasone
Administered by sinonasal irrigation.

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Diceros Therapeutics	Diceros Therapeutics Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Single Ascending Dose (SAD)	The proportion of subjects with Adverse Events at each dose level	1 week
Primary	Part B: Single Dose Component Crossover	Plasma drug levels of Verasone's components	3 weeks
Primary	Part C: Multiple Ascending Dose (MAD)	The proportion of subjects with Adverse Events at each dose level	2 weeks
Secondary	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.	To assess the volume of fluid retained in the sinonasal system following dosing.	30 min