A Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The measurement of pulmonary arterial pressures by echocardiography.
研究概览
简要总结
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Normal male and female volunteers
- •Age 18-55
- •Demonstrate a rise in pulmonary artery pressure to low inspired oxygen concentration (a normal response to breathing a low level of oxygen)
排除标准
- •Significant medical illnesses
- •Risk factors for pulmonary hypertension
- •G6PD or Cytochrome B5 Reductase deficiencies
- •History of any form of altitude sickness
- •Current prescription or over the counter medication use
研究组 & 干预措施
Dose level 1
a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization
干预措施: Sodium Nitrite Inhalation Solution (Drug)
Dose level 2
a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
干预措施: Sodium Nitrite Inhalation Solution (Drug)
Dose level 3
a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
干预措施: Sodium Nitrite Inhalation Solution (Drug)
Dose level 4
a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
干预措施: Sodium Nitrite Inhalation Solution (Drug)
Expansion arm
On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema.
干预措施: Placebo and AIR001 Inhalation Solution (Expansion arm) (Drug)
结局指标
主要结局
The measurement of pulmonary arterial pressures by echocardiography.
时间窗: Pretreatment and up to 2 hours post treatment
次要结局
- Plasma pharmacokinetics(Pretreatment to 8 hours post treatment)
- Hematology, blood chemistry, coagulation and urinalysis, methemoglobin, oxygen saturation, electrocardiogram, troponin, and vital signs and adverse events.(Pretreatment, post treatment, and 24 hours post treatment)