A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray in Healthy Chinese Adult Subjects and Patients With Chronic Rhinosinusitis.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Part 2: To evaluate the safety and tolerability of VVN432 Nasal Spray
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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);
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Part 1: 1% VVN432 Nasal Spray (2 spray/nostril)
1% VVN432 Nasal Spray, single dose, 2 sprays/nostril
干预措施: 1% VVN432 Nasal Spray (Drug)
Part 1: Vehicle
VVN432 Nasal Spray Placebo, single dose, 1 or 2 sprays/nostril
干预措施: Vehicle (Drug)
Part 2: 0.5% VVN432 Nasal Spray (1 spray/nostril)
0.5% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days
干预措施: 0.5% VVN432 Nasal Spray (Drug)
Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril)
0.5% VVN432 Nasal Spray, single dose, 1 spray/nostril
干预措施: 0.5% VVN432 Nasal Spray (Drug)
Part 1: 1% VVN432 Nasal Spray (1 spray/nostril)
1% VVN432 Nasal Spray, single dose, 1 spray/nostril
干预措施: 1% VVN432 Nasal Spray (Drug)
Part 2: 1% VVN432 Nasal Spray (1 spray/nostril)
1% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days
干预措施: 1% VVN432 Nasal Spray (Drug)
Part 2: 1% VVN432 Nasal Spray (2 sprays/nostril)
1% VVN432 Nasal Spray, BID, 2 sprays/nostril, for 28 days
干预措施: 1% VVN432 Nasal Spray (Drug)
Part 2: Vehicle
VVN432 Nasal Spray Placebo, BID, 1 or 2 sprays/nostril, for 28 days
干预措施: Vehicle (Drug)
结局指标
主要结局
Part 2: To evaluate the safety and tolerability of VVN432 Nasal Spray
时间窗: Baseline to Day 35
Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECT, and vital signs
Part 1: To evaluate the safety and tolerability of VVN432 Nasal Spray.
时间窗: Baseline to Day 10
Incidence of the AEs and SAEs; change from baseline in laboratory tests, ECG, and vital signs
次要结局
- 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)
- 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: Efficacy: Total Symptom Score (TSS)(Baseline to Day 35)