Chronic Rhinosinusitis (CRS)Phase 1NCT07259538
A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
A Phase 1 study testing 0.5% VVN432 Nasal Spray and 1% VVN432 Nasal Spray in people with Chronic Rhinosinusitis (CRS), run by VivaVision Biotech, Inc at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis (CRS)
- What is being tested?
- 0.5% VVN432 Nasal Spray and 1% VVN432 Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2025to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Toren Hospital
Beijing
Yan Zou, 86+010-58268486, bjtrec@126.com
About this study
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.
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
- Chronic Rhinosinusitis (CRS)
- Being tested
- 0.5% VVN432 Nasal Spray, 1% VVN432 Nasal Spray, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% VVN432 Nasal SprayDrug
0.5% VVN432 Nasal Spray
1% VVN432 Nasal SprayDrug
1% VVN432 Nasal Spray
VehicleDrug
VVN432 Nasal Spray, Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril) | Experimental | 0.5% VVN432 Nasal Spray, single dose, 1 spray/nostril Receives: Drug: 0.5% VVN432 Nasal Spray |
| Part 1: 1% VVN432 Nasal Spray (1 spray/nostril) | Experimental | 1% VVN432 Nasal Spray, single dose, 1 spray/nostril Receives: Drug: 1% VVN432 Nasal Spray |
| Part 1: 1% VVN432 Nasal Spray (2 spray/nostril) | Experimental | 1% VVN432 Nasal Spray, single dose, 2 sprays/nostril Receives: Drug: 1% VVN432 Nasal Spray |
| Part 1: Vehicle | Placebo comparator | VVN432 Nasal Spray Placebo, single dose, 1 or 2 sprays/nostril Receives: Drug: Vehicle |
| Part 2: 0.5% VVN432 Nasal Spray (1 spray/nostril) | Experimental | 0.5% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days Receives: Drug: 0.5% VVN432 Nasal Spray |
| Part 2: 1% VVN432 Nasal Spray (1 spray/nostril) | Experimental | 1% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days Receives: Drug: 1% VVN432 Nasal Spray |
| Part 2: 1% VVN432 Nasal Spray (2 sprays/nostril) | Experimental | 1% VVN432 Nasal Spray, BID, 2 sprays/nostril, for 28 days Receives: Drug: 1% VVN432 Nasal Spray |
| Part 2: Vehicle | Placebo comparator | VVN432 Nasal Spray Placebo, BID, 1 or 2 sprays/nostril, for 28 days Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to Day 35
Secondary outcomes (6)
Part 1: To evaluate the systemic PK of VVN432 Nasal Spray
Plasma concentration of VVN432, and assess the PK parameters if applicable
Measured: 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
Measured: 48 hours
Part 2: To evaluate the systemic PK of VVN432 Nasal Spray
Plasma concentration of VVN432, and assess the PK parameters if applicable
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start6 Nov 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (CRS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VivaVision Biotech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259538
- Sponsor's protocol ID
- VVN432-CCS-101
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07259538
- Acronym / sponsor ID
- VVN432-CCS-101
- Conditions
- Chronic Rhinosinusitis (CRS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VivaVision Biotech, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril) | Experimental | Drug: 0.5% VVN432 Nasal Spray0.5% VVN432 Nasal Spray, single dose, 1 spray/nostril |
| Part 1: 1% VVN432 Nasal Spray (1 spray/nostril) | Experimental | Drug: 1% VVN432 Nasal Spray1% VVN432 Nasal Spray, single dose, 1 spray/nostril |
| Part 1: 1% VVN432 Nasal Spray (2 spray/nostril) | Experimental | Drug: 1% VVN432 Nasal Spray1% VVN432 Nasal Spray, single dose, 2 sprays/nostril |
| Part 1: Vehicle | Placebo comparator | Drug: VehicleVVN432 Nasal Spray Placebo, single dose, 1 or 2 sprays/nostril |
| Part 2: 0.5% VVN432 Nasal Spray (1 spray/nostril) | Experimental | Drug: 0.5% VVN432 Nasal Spray0.5% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days |
| Part 2: 1% VVN432 Nasal Spray (1 spray/nostril) | Experimental | Drug: 1% VVN432 Nasal Spray1% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days |
| Part 2: 1% VVN432 Nasal Spray (2 sprays/nostril) | Experimental | Drug: 1% VVN432 Nasal Spray1% VVN432 Nasal Spray, BID, 2 sprays/nostril, for 28 days |
| Part 2: Vehicle | Placebo comparator | Drug: VehicleVVN432 Nasal Spray Placebo, BID, 1 or 2 sprays/nostril, for 28 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
- Male or female patients aged 18 to 55 years old (inclusive);
- Clinically confirmed diagnosis of chronic rhinosinusitis with or without nasal polyps;
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% VVN432 Nasal Spray0.5% VVN432 Nasal Spray | Drug | Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril), Part 2: 0.5% VVN432 Nasal Spray (1 spray/nostril) |
| 1% VVN432 Nasal Spray1% VVN432 Nasal Spray | Drug | Part 1: 1% VVN432 Nasal Spray (1 spray/nostril), Part 1: 1% VVN432 Nasal Spray (2 spray/nostril), Part 2: 1% VVN432 Nasal Spray (1 spray/nostril), Part 2: 1% VVN432 Nasal Spray (2 sprays/nostril) |
| VehicleVVN432 Nasal Spray, Placebo | Drug | Part 1: Vehicle, Part 2: Vehicle |
Primary outcome
Part 1: To evaluate the safety and tolerability of VVN432 Nasal Spray.
Time frame: Baseline to Day 10
Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECG, and vital signs
Part 2: To evaluate the safety and tolerability of VVN432 Nasal Spray
Time frame: Baseline to Day 35
Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECT, and vital signs
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.5% VVN432 Nasal Spray and 1% VVN432 Nasal Spray in people with Chronic Rhinosinusitis (CRS), run by VivaVision Biotech, Inc at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Lu (86-18816562189, caroline.lu@vivavisionbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: To evaluate the safety and tolerability of VVN432 Nasal Spray. (time frame: Baseline to Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.