Pulmonary Arterial Hypertension
Conditions
Brief summary
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.
Interventions
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
DRUGPlacebo and AIR001 Inhalation Solution (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.
Sponsors
Aires Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measurement of pulmonary arterial pressures by echocardiography. | Pretreatment and up to 2 hours post treatment |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed