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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Toren Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Caroline Lu
• Email: caroline.lu@vivavisionbio.com
• Phone: 86-18816562189

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.