NCT07259538 A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray
| NCT ID | NCT07259538 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | VivaVision Biotech, Inc |
| Condition | Chronic Rhinosinusitis (CRS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-11-06 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07259538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Chronic Rhinosinusitis (CRS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07259538 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07259538 currently recruiting?
Yes, NCT07259538 is actively recruiting participants. Contact the research team at caroline.lu@vivavisionbio.com for enrollment information.
Where is the NCT07259538 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07259538 clinical trial?
NCT07259538 is sponsored by VivaVision Biotech, Inc. The trial plans to enroll 60 participants.