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Recruiting Phase 1

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

NCT07259538 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-11-06
Last updated
2025-12-02

Condition(s) studied

Chronic Rhinosinusitis (CRS)

Investigational drug(s) / intervention(s)

0.5% VVN432 Nasal Spray1% VVN432 Nasal SprayVehicle

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

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: Part 1: * Healthy male or female subjects aged 18 to 55 years old (inclusive); * Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) within the range of 18.5 to 28.0 kg/m2 (inclusive); * No clinically significant abnormalities at screening or baseline. Part 2: * Male or female patients aged 18 to 55 years old (inclusive); * Clinically confirmed diagnosis of chronic rhinosinusitis with or without nasal polyps; * Presence of the following symptoms for \>4 weeks before screening: nasal obstruction, mucous or mucopurulent rhinorrhea, facial pain/pressure, and reduced or lost sense of smell; * Modified Lund-Kennedy (MLK) score ≥ 2 in each nostril by nasal endoscopy; * Lund-Mackay score (LMK) ≥ 2 in each nostril by CT scan; * Nasal Construction Score (NCS) ≥ 2. Exclusion Criteria: Part 1: * Known hypersensitivity or contraindications to the study drug or its components; * History or current conditions that affect the safety or absorption of the investigational drug; * History of drug abuse or drug dependence; * Participation in any other clinical trials and receiving an investigational drug within 12 weeks before screening or 5 half-lives, whichever is longer; * If female, is pregnant or lactating, or intends to become pregnant during the study period. Part 2: * Known hypersensitivity or contraindications to the study drug or its components; * Use of prohibited medications prior to screening and during the course of the study; History of drug abuse or drug dependence; * Participation in any other clinical trials and receiving an investigational drug within 12 weeks before screening or 5 half-lives, whichever is longer; * If female, is pregnant or lactating, or intends to become pregnant during the study period.

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)

FacilityCityRegionStatus
Beijing Toren Hospital Beijing China Recruiting
Official registry record

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