VVN432 nasal spray safety and early testing in healthy adults and people with chronic rhinosinusitis

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.

This will test whether VVN432 nasal spray is safe and how the body processes it in healthy adults and in people with chronic rhinosinusitis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: VivaVision Biotech, Inc (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07259538 on ClinicalTrials.gov

What this trial studies

The program has two parts: a single-ascending-dose (Phase 1a) single-center, randomized, double-masked, vehicle-controlled stage in healthy adults to characterize safety, tolerability, and pharmacokinetics, and a multiple-ascending-dose (Phase 1b) multi-center, randomized, double-masked, vehicle-controlled stage in patients with chronic rhinosinusitis to evaluate safety, tolerability, PK/PD, and preliminary efficacy. Participants will receive either 0.5% or 1% VVN432 nasal spray or vehicle control and undergo serial safety and PK sampling. CRS patients will also be assessed with nasal endoscopy and CT-based scores and symptom measures to detect early signs of efficacy. The study focuses on short-term tolerability and how the drug is absorbed and processed when delivered intranasally.

Who should consider this trial

Good fit: Ideal candidates are adults 18–55 years old with a confirmed diagnosis of chronic rhinosinusitis (with or without nasal polyps), ongoing nasal symptoms for more than four weeks, and meeting the specified endoscopy and CT score thresholds.

Not a fit: People outside the required age or BMI ranges, those with known hypersensitivity to the study drug, or those who do not meet the required endoscopy or CT criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, VVN432 could become a new topical nasal option that reduces CRS symptoms while limiting systemic exposure compared with oral treatments.

How similar studies have performed: Intranasal therapies such as steroid sprays have proven benefit for CRS, but VVN432 is a novel compound and this Phase 1 program is early-stage and unproven.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Toren Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Caroline Lu

Conditions Chronic Rhinosinusitis