Chronic Rhinosinusitis (CRS)
Conditions
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.
Interventions
DRUG0.5% VVN432 Nasal Spray
0.5% VVN432 Nasal Spray
DRUG1% VVN432 Nasal Spray
1% VVN432 Nasal Spray
DRUGVehicle
VVN432 Nasal Spray, Placebo
Sponsors
VivaVision Biotech, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: To evaluate the safety and tolerability of VVN432 Nasal Spray. | 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 | Baseline to Day 35 | Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECT, and vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: To evaluate the systemic PK of VVN432 Nasal Spray | Day 1, Day 28, and Day 35 | Plasma concentration of VVN432, and assess the PK parameters if applicable |
| Part 2: To evaluate the local PK of VVN432 Nasal Spray | Day 1, Day 28, and Day 35 | Local concentration of VVN432 in the eluent of nasal swabs post-dose |
| Part 1: To evaluate the systemic PK of VVN432 Nasal Spray | 48 hours | Plasma concentration of VVN432, and assess the PK parameters if applicable |
| Part 2: Efficacy: Total Symptom Score (TSS) | Baseline to Day 35 | 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) |
| Part 2: Efficacy: Nasal Congestion Score (NCS) | Baseline to Day 35 | Change from baseline in NCS (0-3, higher scores indicate more severe symptoms) |
| Part 1: To evaluate the local PK of VVN432 Nasal Spray | 48 hours | Local concentration of VVN432 in the eluent of oropharyngeal swabs and nasal swabs, and in nasal lavage fluid post-dose |
Countries
China
Contacts
Primary ContactCaroline Lu
Outcome results
None listed