25
Participants
Start Date
December 31, 2008
Primary Completion Date
April 30, 2009
Study Completion Date
June 30, 2009
Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
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.
DaVita Clinical Research, Minneapolis
Lead Sponsor
Aires Pharmaceuticals, Inc.
INDUSTRY