This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded
dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in
subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least
six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to
receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15
minutes. Three cohorts of subjects were enrolled to the study and safety and pharmacokinetics
of the study treatment were evaluated.