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

Sponsor

Diceros Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06147921

Collaborator

Diceros Therapeutics Australia Pty Ltd (Industry)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Verasone	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double-Blind, Placebo-Controlled

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 15, 2023

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAD Dose Level 1 Sinonasal irrigation of lowest dose Verasone vs placebo	Drug: Verasone Administered by sinonasal irrigation.
Experimental: SAD Dose Level 2 Sinonasal irrigation of second lowest dose Verasone vs placebo	Drug: Verasone Administered by sinonasal irrigation.
Experimental: SAD Dose Level 3 Sinonasal irrigation of third lowest dose Verasone vs placebo	Drug: Verasone Administered by sinonasal irrigation.
Experimental: SAD Dose Level 4 Sinonasal irrigation of highest dose Verasone vs placebo	Drug: Verasone Administered by sinonasal irrigation.
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.	Drug: Verasone Administered by sinonasal irrigation.
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	Drug: Verasone Administered by sinonasal irrigation.
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.	Drug: Verasone Administered by sinonasal irrigation.

Outcome Measures

Primary Outcome Measures

Part A: Single Ascending Dose (SAD) [1 week]
The proportion of subjects with Adverse Events at each dose level
Part B: Single Dose Component Crossover [3 weeks]
Plasma drug levels of Verasone's components
Part C: Multiple Ascending Dose (MAD) [2 weeks]
The proportion of subjects with Adverse Events at each dose level

Secondary Outcome Measures

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]
To assess the volume of fluid retained in the sinonasal system following dosing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

Diceros Therapeutics
Diceros Therapeutics Australia Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Diceros Therapeutics

ClinicalTrials.gov Identifier:

NCT06147921

Other Study ID Numbers:

VER-001

First Posted:

Nov 28, 2023

Last Update Posted:

Nov 28, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Nov 28, 2023