MedTrace Logo

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

NCT06147921 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-01-23

No results posted yet for this study

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

Interventions

DRUG

Verasone

Administered by sinonasal irrigation.

Sponsors & Collaborators

  • Diceros Therapeutics Australia Pty Ltd

    collaborator INDUSTRY

  • Diceros Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2024-12-13
Completion
2024-12-13
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147921 on ClinicalTrials.gov