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.
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.
Male or female patients aged 18 to 55 years old (inclusive);
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;
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Treatment groupsSee each treatment group below.