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RECRUITING
NCT07259538
PHASE1

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

Sponsor: VivaVision Biotech, Inc

View on ClinicalTrials.gov

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.

Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray in Healthy Chinese Adult Subjects and Patients With Chronic Rhinosinusitis.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-11-06

Completion Date

2026-11-30

Last Updated

2025-12-02

Healthy Volunteers

Yes

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

Locations (1)

Beijing Toren Hospital

Beijing, China