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

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

June 30, 2009

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Sodium Nitrite Inhalation Solution

a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization

DRUG

Placebo 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.

Trial Locations (1)

55404

DaVita Clinical Research, Minneapolis

Sponsors
All Listed Sponsors
lead

Aires Pharmaceuticals, Inc.

INDUSTRY

NCT00814645 - Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers | Biotech Hunter | Biotech Hunter