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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Active Comparator | a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization |
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| Dose level 2 | Active Comparator | a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization |
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| Dose level 3 | Active Comparator | a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization |
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| Dose level 4 | Active Comparator | a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization |
|
| Expansion arm | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Nitrite Inhalation Solution | Drug | a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization |
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| Measure | Description | Time Frame |
|---|---|---|
| The measurement of pulmonary arterial pressures by echocardiography. | Pretreatment and up to 2 hours post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne K Swan, M.D. | Davita Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
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| Placebo and AIR001 Inhalation Solution (Expansion arm) | Drug | 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. |
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|
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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