Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency
研究概览
简要总结
This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19
详细描述
This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19
64 subjects will be sequentially enrolled to receive dosage of UNI911 INHALATION or placebo. 4 sentinel subjects (one per cohort 1, 2 ,3 and 4 ) will be treated in an open-label manner to confirm the safety of each dose sequentially. 40 subjects will be randomly assigned (3:1) to either active or placebo. For the last 2 cohorts, a total of 20 healthy volunteers will be enrolled to receive multiple doses of UNI911 INHALATION.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Single dose of UNI911 inhalation (4 mL 0.1% ~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)
干预措施: UNI911 inhalation 1% and intranasal spray 1% (Drug)
Cohort 1
Single dose of UNI911 inhalation (4 mL 0.1% ~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)
干预措施: Placebo (Drug)
Cohort 2
Single dose of UNI911 inhalation (1 mL 1% ~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)
干预措施: UNI911 inhalation 1% and intranasal spray 1% (Drug)
Cohort 2
Single dose of UNI911 inhalation (1 mL 1% ~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)
干预措施: Placebo (Drug)
Cohort 3
Single dose of UNI911 inhalation (3 mL 1% ~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)
干预措施: UNI911 inhalation 1% and intranasal spray 1% (Drug)
Cohort 3
Single dose of UNI911 inhalation (3 mL 1% ~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)
干预措施: Placebo (Drug)
Cohort 4
Single dose of UNI911 inhalation (6 mL 1% ~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)
干预措施: UNI911 inhalation 1% and intranasal spray 1% (Drug)
Cohort 4
Single dose of UNI911 inhalation (6 mL 1% ~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)
干预措施: Placebo (Drug)
Cohort 5
UNI911 inhalation (6 mL 1% ~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 2,5 days.
干预措施: UNI911 inhalation 1% and intranasal spray 1% (Drug)
Cohort 5
UNI911 inhalation (6 mL 1% ~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 2,5 days.
干预措施: Placebo (Drug)
Cohort 6
UNI911 inhalation (1 mL 1% ~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 6,5 days.
干预措施: UNI911 inhalation 1% and intranasal spray 1% (Drug)
Cohort 7
UNI911 inhalation (3 mL 1% ~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 6,5 days.
干预措施: UNI911 inhalation 1% and intranasal spray 1% (Drug)
Placebo (applicable for cohorts 1-5)
Placebo, administered in a double-blinded fashion (except for the first subjects of cohorts 1-4) at the same dose and frequency as UNI911 inhalation and intranasal spray.
干预措施: Placebo (Drug)
结局指标
主要结局
Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency
时间窗: Up to Day 6
AE frequency in each cohort and treatment group
次要结局
未报告次要终点