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

NCT ID: NCT07259538

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-06
• Study Completion Date: 2026-11-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

0.5% VVN432 Nasal Spray

Intervention Type: DRUG

0.5% VVN432 Nasal Spray

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

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

Group Type: EXPERIMENTAL

1% VVN432 Nasal Spray

Intervention Type: DRUG

1% VVN432 Nasal Spray

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

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

Group Type: EXPERIMENTAL

1% VVN432 Nasal Spray

Intervention Type: DRUG

1% VVN432 Nasal Spray

Part 1: Vehicle

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

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

VVN432 Nasal Spray, Placebo

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

0.5% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days

Group Type: EXPERIMENTAL

0.5% VVN432 Nasal Spray

Intervention Type: DRUG

0.5% VVN432 Nasal Spray

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

1% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days

Group Type: EXPERIMENTAL

1% VVN432 Nasal Spray

Intervention Type: DRUG

1% VVN432 Nasal Spray

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

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

Group Type: EXPERIMENTAL

1% VVN432 Nasal Spray

Intervention Type: DRUG

1% VVN432 Nasal Spray

Part 2: Vehicle

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

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

VVN432 Nasal Spray, Placebo

Interventions

0.5% VVN432 Nasal Spray

0.5% VVN432 Nasal Spray

Intervention Type: DRUG

1% VVN432 Nasal Spray

1% VVN432 Nasal Spray

Intervention Type: DRUG

Vehicle

VVN432 Nasal Spray, Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VivaVision Biotech, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Toren Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Caroline Lu

Role: CONTACT

caroline.lu@vivavisionbio.com

86-18816562189

Facility Contacts

Yan Zou

Role: primary

bjtrec@126.com

86+010-58268486

Other Identifiers

VVN432-CCS-101

Identifier Type: -

Identifier Source: org_study_id