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

NCT07259538 | Recruiting Phase 1

• 1 other identifier: VVN432-CCS-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (CRS)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline to Day 35

Secondary Outcomes (6)

• Part 1: To evaluate the systemic PK of VVN432 Nasal Spray

  48 hours

• Part 1: To evaluate the local PK of VVN432 Nasal Spray

  48 hours

• Part 2: To evaluate the systemic PK of VVN432 Nasal Spray

  Day 1, Day 28, and Day 35

• Part 2: To evaluate the local PK of VVN432 Nasal Spray

  Day 1, Day 28, and Day 35

• Part 2: Efficacy: Nasal Congestion Score (NCS)

  Baseline to Day 35

Study Arms (8)

Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril)

EXPERIMENTAL

0.5% VVN432 Nasal Spray, single dose, 1 spray/nostril

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

Drug: 1% VVN432 Nasal Spray

Part 1: 1% VVN432 Nasal Spray (2 spray/nostril)

EXPERIMENTAL

1% VVN432 Nasal Spray, single dose, 2 sprays/nostril

Drug: 1% VVN432 Nasal Spray

Part 1: Vehicle

PLACEBO COMPARATOR

VVN432 Nasal Spray Placebo, single dose, 1 or 2 sprays/nostril

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

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

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

Drug: 1% VVN432 Nasal Spray

Part 2: Vehicle

PLACEBO COMPARATOR

VVN432 Nasal Spray Placebo, BID, 1 or 2 sprays/nostril, for 28 days

Drug: Vehicle

Interventions

0.5% VVN432 Nasal Spray DRUG

0.5% VVN432 Nasal Spray

Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril); Part 2: 0.5% VVN432 Nasal Spray (1 spray/nostril)

1% VVN432 Nasal Spray DRUG

1% VVN432 Nasal Spray

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)

Vehicle DRUG

VVN432 Nasal Spray, Placebo

Part 1: Vehicle; Part 2: Vehicle

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VivaVision Biotech, Inc: lead

Study Sites (1)

Beijing Toren Hospital

Beijing, China

RECRUITING

Central Study Contacts

Caroline Lu

CONTACT

86-18816562189; caroline.lu@vivavisionbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 2, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)