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A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray

NCT07259538 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-02

No results posted yet for this study

Summary

The goal of this clinical study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VVN432 Nasal Spray in healthy volunteers (Phase Ia) and in patients with chronic rhinosinusitis (Phase 1b).

This study consists of two parts (Phase 1a and Phase 1b):

Phase 1a (SAD) is a single-center, randomized, double-masked, vehicle-controlled study to assess the safety, tolerability, and PK of VVN432 Nasal Spray in healthy adult subjects.

Phase 1b (MAD) is a multi-center, randomized, double-masked, vehicle-controlled study to assess the safety, tolerability, PK/PD, and preliminary efficacy of VVN432 Nasal Spray in patients with chronic rhinosinusitis.

Conditions

  • Chronic Rhinosinusitis (CRS)

Interventions

DRUG

0.5% VVN432 Nasal Spray

0.5% VVN432 Nasal Spray

DRUG

1% VVN432 Nasal Spray

1% VVN432 Nasal Spray

DRUG

Vehicle

VVN432 Nasal Spray, Placebo

Sponsors & Collaborators

  • VivaVision Biotech, Inc

    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
2025-11-06
Primary Completion
2026-07-30
Completion
2026-11-30

Countries

  • China

Study Locations

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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 NCT07259538 on ClinicalTrials.gov