A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
Condition(s) studied
Investigational drug(s) / intervention(s)
0.5% VVN432 Nasal Spray: 0.5% VVN432 Nasal Spray
1% VVN432 Nasal Spray: 1% VVN432 Nasal Spray
Vehicle: VVN432 Nasal Spray, Placebo
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.
Eligibility
Primary outcome measure(s)
- Part 1: To evaluate the safety and tolerability of VVN432 Nasal Spray. — Baseline to Day 10
Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECG, and vital signs - Part 2: To evaluate the safety and tolerability of VVN432 Nasal Spray — Baseline to Day 35
Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECT, and vital signs
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Toren Hospital | Beijing | China | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07259538 on ClinicalTrials.gov ↗ ← All trials in China