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

NCT06147921 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VER-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Part A: Single Ascending Dose (SAD)

  The proportion of subjects with Adverse Events at each dose level

  1 week

• Part B: Single Dose Component Crossover

  Plasma drug levels of Verasone's components

  3 weeks

• Part C: Multiple Ascending Dose (MAD)

  The proportion of subjects with Adverse Events at each dose level

  2 weeks

Secondary Outcomes (1)

• 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.

  30 min

Study Arms (7)

SAD Dose Level 1

EXPERIMENTAL

Sinonasal irrigation of lowest dose Verasone vs placebo

Drug: Verasone

SAD Dose Level 2

EXPERIMENTAL

Sinonasal irrigation of second lowest dose Verasone vs placebo

Drug: Verasone

SAD Dose Level 3

EXPERIMENTAL

Sinonasal irrigation of third lowest dose Verasone vs placebo

Drug: Verasone

SAD Dose Level 4

EXPERIMENTAL

Sinonasal irrigation of highest dose Verasone vs placebo

Drug: Verasone

Crossover Component

ACTIVE COMPARATOR

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.

Drug: Verasone

MAD Dose Level 1

EXPERIMENTAL

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

Drug: Verasone

MAD Dose Level 2

EXPERIMENTAL

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.

Drug: Verasone

Interventions

Verasone DRUG

Administered by sinonasal irrigation.

Crossover Component; MAD Dose Level 1; MAD Dose Level 2; SAD Dose Level 1; SAD Dose Level 2; SAD Dose Level 3; SAD Dose Level 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diceros Therapeutics: lead
• Diceros Therapeutics Australia Pty Ltd: collaborator

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind, Placebo-Controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Ascending Dose (SAD), Single Dose Active Components PK Crossover, Multiple Ascending Dose (MAD)

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 28, 2023
• Study Start: December 15, 2023
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)