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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
0.5% VVN432 Nasal Spray
1% VVN432 Nasal Spray
VVN432 Nasal Spray, Placebo
Beijing Toren Hospital
Beijing, China
RECRUITINGPart 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
Time frame: 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
Time frame: Baseline to Day 35
Part 1: To evaluate the systemic PK of VVN432 Nasal Spray
Plasma concentration of VVN432, and assess the PK parameters if applicable
Time frame: 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
Time frame: 48 hours
Part 2: To evaluate the systemic PK of VVN432 Nasal Spray
Plasma concentration of VVN432, and assess the PK parameters if applicable
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline to Day 35
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