Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome

Inclusion Criteria

• ≥ 18 years
• Suspected or proven bacterial infection
• Receiving positive pressure ventilation through an endotracheal tube
• Have ALI/ARDS, defined as having all of the following:
• bilateral infiltrates consistent with pulmonary edema
• Hypoxemia
• no clinical evidence of left atrial hypertension
• Provide signed informed consent

Exclusion Criteria

• Mechanically or chemically-induced ALI/ARDS (including burns, trauma, and near drowning)
• End-stage lung disease
• Decompensated congestive heart failure
• Authorization to withdraw life support
• Hemoglobin persistently 15,000 units/day
• Low molecular weight heparins
• Warfarin if used within 7 days prior to study drug infusion
• Thrombolytic treatment within 3 days prior to study drug infusion
• 8Glycoprotein IIb/IIIa antagonists within 7 days prior to study drug infusion
• Aspirin or any aspirin containing compound within 3 days prior to study drug infusion
• APC infusion within 72 hours prior to study drug infusion
• Major trauma or trauma subjects at an increased risk of bleeding
• History of severe head trauma that required hospitalization, intracranial surgery, or stroke or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion with an epidural catheter or who anticipate receiving an epidural catheter during study drug infusion
• Major surgery within the previous 3 days, any postoperative subject with evidence of active bleeding, or any subject with planned or anticipated surgery within 72 hours after study drug infusion. History of abnormal bleeding during surgical procedures
• Chronic renal failure, defined as a calculated glomerular filtration rate (GFR) ≤20 mL/min
• Subjects with baseline aspartate transaminase (AST) or alanine transaminase (ALT) level >5 times the upper limit of normal. Subjects with known esophageal varices, chronic jaundice, biopsy proven cirrhosis, or chronic ascites
• History of organ transplant (including bone marrow)
• Subjects with malignancy having a life expectancy <6 months
• Known human immunodeficiency virus (HIV) positive with CD4+ T Cell count <200/uL
• Women who are pregnant or nursing
• Participation in another clinical research study within 30 days before administration of study drug, with the exception of participation in studies involving noninvasive monitoring medical devices
• Any prior treatment with a murine or chimeric antibody
• Subjects who are moribund and where death is perceived to be imminent (within 72 hours after screening)
• Subjects who have persistent hypotension not responding to fluid or vasopressor administration; subjects who require more than two vasopressors 26. Any medical condition which in the opinion of the investigator would interfere with optimal participation in the study or that would produce a significant risk to a subject