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A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
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.
Details
| Lead sponsor | VivaVision Biotech, Inc |
|---|---|
| Phase | PHASE1 |
| Status | RECRUITING |
| Enrolment | 60 |
| Start date | Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Nov 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Chronic Rhinosinusitis (CRS)
Interventions
- 0.5% VVN432 Nasal Spray
- 1% VVN432 Nasal Spray
- Vehicle
Countries
China