Phase 1 Study of VVN432 Nasal Spray to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Adults and Patients with Chronic Rhinosinusitis

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of VVN432 Nasal Spray in both healthy adults and patients with chronic rhinosinusitis CRS. This clinical study has two parts Phase 1a focuses on healthy volunteers to assess safety and drug behavior, while Phase 1b involves patients with CRS to also evaluate preliminary efficacy. The trial includes adults aged 18 to 55 years and aims to better understand how this nasal spray works and its safety profile in these groups. The study tests different doses and regimens of VVN432 Nasal Spray, including single and multiple doses. In Phase 1a, healthy subjects receive single doses of 0.5% or 1% spray, one or two sprays per nostril, or placebo. In Phase 1b, patients use the nasal spray twice daily for 28 days, with similar dosing groups and placebo controls. Both phases are randomized, double-masked, and vehicle-controlled to compare effects accurately. Participants will undergo regular safety and tolerability assessments from baseline to Day 10 for Phase 1a and to Day 35 for Phase 1b. Pharmacokinetic measurements of VVN432 will be taken at various time points to monitor drug levels locally and systemically. Patients with CRS will also have symptom scores recorded to evaluate nasal congestion and overall symptoms. The total participation time varies by study part, with detailed monitoring to ensure participant safety and collect important data on the nasal sprays effects.

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