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Recruiting NCT07259538

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

Phase I Interventional Chronic Rhinosinusitis (CRS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 0.5% VVN432 Nasal Spray, 1% VVN432 Nasal Spray, Vehicle.
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis (CRS). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Drug 0.5% VVN432 Nasal Spray
    0.5% VVN432 Nasal Spray
  • Drug 1% VVN432 Nasal Spray
    1% VVN432 Nasal Spray
  • Drug Vehicle
    VVN432 Nasal Spray, Placebo

Primary outcome measures

  • Part 1: To evaluate the safety and tolerability of VVN432 Nasal Spray. [Time frame: Baseline to Day 10]
  • Part 2: To evaluate the safety and tolerability of VVN432 Nasal Spray [Time frame: Baseline to Day 35]
Secondary outcome measures (6)
  • Part 1: To evaluate the systemic PK of VVN432 Nasal Spray [Time frame: 48 hours]
  • Part 1: To evaluate the local PK of VVN432 Nasal Spray [Time frame: 48 hours]
  • Part 2: To evaluate the systemic PK of VVN432 Nasal Spray [Time frame: Day 1, Day 28, and Day 35]
  • Part 2: To evaluate the local PK of VVN432 Nasal Spray [Time frame: Day 1, Day 28, and Day 35]
  • Part 2: Efficacy: Nasal Congestion Score (NCS) [Time frame: Baseline to Day 35]
  • Part 2: Efficacy: Total Symptom Score (TSS) [Time frame: Baseline to Day 35]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Toren Hospital — Beijing

Identifiers

NCT: NCT07259538 · VVN432-CCS-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗