Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers (AIR001-CS02)

Aires Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Sodium Nitrite Inhalation Solution; Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814645

AIR001 CS02

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 5 patient groups, including a placebo group

Dose level 1

Active Comparator group

Description:

a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization

Treatment:

Drug: Sodium Nitrite Inhalation Solution

Dose level 2

Active Comparator group

Description:

a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

Treatment:

Drug: Sodium Nitrite Inhalation Solution

Dose level 3

Active Comparator group

Description:

a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

Treatment:

Drug: Sodium Nitrite Inhalation Solution

Dose level 4

Active Comparator group

Description:

a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

Treatment:

Drug: Sodium Nitrite Inhalation Solution

Expansion arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)