1
Participants
Start Date
June 30, 2008
Primary Completion Date
December 31, 2009
Study Completion Date
December 31, 2009
Treprostinil sodium for inhalation
"Administration of inhaled treprostinil sodium 0.6 mg/ml in 3mL ampoules Duration of Treatment: single dose~Dose:~* Cohort 1: dosed at 3 breaths (18 mcg)~* Cohort 2: dosed at 6 breaths (36 mcg)~* Cohort 3: dosed at 9 breaths (54 mcg)~* Cohort 4: dosed at 12 breaths (72 mcg)~The decision to advance to the next cohort will be made after review of all safety information including vital signs, physical examination, clinical laboratory tests, ECGs, and adverse events."
Inova Heart and Vascular Institute, Falls Church
UCSD Medical Center m/c7381, La Jolla
UC Davis Medical Center/Advanced Lung Disease and LungTransplant Program, Sacramento
University of Michigan, Ann Arbor
Vanderbilt University Medical Center, Nashville
UTWS Medical Center Dallas/St. Paul Univ. Hospital, Dallas
Lead Sponsor
Lung Biotechnology PBC
INDUSTRY