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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Rhinosinusitis (CRS)
• Intervention / Treatment: Drug: 0.5% VVN432 Nasal Spray; Drug: 1% VVN432 Nasal Spray; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Caroline Lu; Phone Number: 86-18816562189; Email: caroline.lu@vivavisionbio.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Toren Hospital
    • Contact: Yan Zou; Phone Number: 86+010-58268486; Email: bjtrec@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril); 0.5% VVN432 Nasal Spray, single dose, 1 spray/nostril	Drug: 0.5% VVN432 Nasal Spray; 0.5% VVN432 Nasal Spray
Experimental: Part 1: 1% VVN432 Nasal Spray (1 spray/nostril); 1% VVN432 Nasal Spray, single dose, 1 spray/nostril	Drug: 1% VVN432 Nasal Spray; 1% VVN432 Nasal Spray
Experimental: Part 1: 1% VVN432 Nasal Spray (2 spray/nostril); 1% VVN432 Nasal Spray, single dose, 2 sprays/nostril	Drug: 1% VVN432 Nasal Spray; 1% VVN432 Nasal Spray
Placebo Comparator: Part 1: Vehicle; VVN432 Nasal Spray Placebo, single dose, 1 or 2 sprays/nostril	Drug: Vehicle; VVN432 Nasal Spray, Placebo
Experimental: Part 2: 0.5% VVN432 Nasal Spray (1 spray/nostril); 0.5% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days	Drug: 0.5% VVN432 Nasal Spray; 0.5% VVN432 Nasal Spray
Experimental: Part 2: 1% VVN432 Nasal Spray (1 spray/nostril); 1% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days	Drug: 1% VVN432 Nasal Spray; 1% VVN432 Nasal Spray
Experimental: Part 2: 1% VVN432 Nasal Spray (2 sprays/nostril); 1% VVN432 Nasal Spray, BID, 2 sprays/nostril, for 28 days	Drug: 1% VVN432 Nasal Spray; 1% VVN432 Nasal Spray
Placebo Comparator: Part 2: Vehicle; VVN432 Nasal Spray Placebo, BID, 1 or 2 sprays/nostril, for 28 days	Drug: Vehicle; VVN432 Nasal Spray, Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: To evaluate the safety and tolerability of VVN432 Nasal Spray.	Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECG, and vital signs	Baseline to Day 10
Part 2: To evaluate the safety and tolerability of VVN432 Nasal Spray	Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECT, and vital signs	Baseline to Day 35

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: To evaluate the systemic PK of VVN432 Nasal Spray	Plasma concentration of VVN432, and assess the PK parameters if applicable	48 hours
Part 1: To evaluate the local PK of VVN432 Nasal Spray	Local concentration of VVN432 in the eluent of oropharyngeal swabs and nasal swabs, and in nasal lavage fluid post-dose	48 hours
Part 2: To evaluate the systemic PK of VVN432 Nasal Spray	Plasma concentration of VVN432, and assess the PK parameters if applicable	Day 1, Day 28, and Day 35
Part 2: To evaluate the local PK of VVN432 Nasal Spray	Local concentration of VVN432 in the eluent of nasal swabs post-dose	Day 1, Day 28, and Day 35
Part 2: Efficacy: Nasal Congestion Score (NCS)	Change from baseline in NCS (0-3, higher scores indicate more severe symptoms)	Baseline to Day 35
Part 2: Efficacy: Total Symptom Score (TSS)	Change from Baseline in TSS (0-9 [sum of NCS, loss of smell, and average of anterior and posterior rhinorrhea], higher scores indicate more severe symptoms)	Baseline to Day 35

Collaborators and Investigators

• Sponsor: VivaVision Biotech, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: VVN432-CCS-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No