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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
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.
DaVita Clinical Research
Minneapolis, Minnesota, United States
The measurement of pulmonary arterial pressures by echocardiography.
Time frame: Pretreatment and up to 2 hours post treatment
Plasma pharmacokinetics
Time frame: Pretreatment to 8 hours post treatment
Hematology, blood chemistry, coagulation and urinalysis, methemoglobin, oxygen saturation, electrocardiogram, troponin, and vital signs and adverse events.
Time frame: Pretreatment, post treatment, and 24 hours post treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.