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A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
Sponsor: VivaVision Biotech, Inc
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
Conditions
Interventions
0.5% VVN432 Nasal Spray
0.5% VVN432 Nasal Spray
1% VVN432 Nasal Spray
1% VVN432 Nasal Spray
Vehicle
VVN432 Nasal Spray, Placebo
Locations (1)
Beijing Toren Hospital
Beijing, China