NCT07259538

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

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: VivaVision Biotech, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-11-06
• Primary completion: 2026-07-30
• Completion: 2026-11-30
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China