This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in:
San Diego, California, United States
Measures of the safety and tolerability of AIR645 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, pulmonary function tests, heart rhythm, and laboratory tests.
Time frame: During dosing and for two weeks after dosing
Bioavailability
Time frame: During dosing and for two weeks after dosing
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