Actively Recruiting
A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
Led by VivaVision Biotech, Inc · Updated on 2025-12-02
60
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males or females aged 18 to 55 years
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
- Body mass index (BMI) between 18.5 to 28.0 kg/m2
- No significant clinical abnormalities at screening or baseline
- Patients aged 18 to 55 years with confirmed chronic rhinosinusitis with or without nasal polyps
- Presence of nasal obstruction, mucous or mucopurulent rhinorrhea, facial pain/pressure, and reduced or lost sense of smell for more than 4 weeks
- Modified Lund-Kennedy score ≥ 2 in each nostril by nasal endoscopy
- Lund-Mackay score ≥ 2 in each nostril by CT scan
- Nasal Construction Score ≥ 2
You will not qualify if you...
- Known hypersensitivity or contraindications to the study drug or its components
- History or current conditions affecting safety or absorption of the investigational drug
- History of drug abuse or dependence
- Participation in other clinical trials or receiving investigational drugs within 12 weeks before screening or 5 half-lives, whichever is longer
- Females who are pregnant, lactating, or intending to become pregnant during the study period
- Use of prohibited medications prior to screening and during the study (for patients)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Toren Hospital
Beijing, China
Actively Recruiting
Research Team
C
Caroline Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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