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

Completed · Phase 1 · Has a placebo group

Conditions studied: Sepsis, Acute Lung Injury, Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT01438853

Run by

Altor BioScience

People needed

18

Starts

2004-12-01

Expected to finish

2008-02-01

Last updated by the study team

2025-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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 <8.0 g/dL
• Subjects who have any one of the following:
• platelet count <50,000/mm\^3
• prolonged prothrombin time (PT)
• prolonged activated partial thromboplastin time (aPTT)
• having significant potential for disseminated intravascular coagulation (DIC)
• Subjects who have two or more of the following:
• prolonged aPTT
• fibrinogen level below the lower limit of normal
• presence of petechiae, ecchymoses, or other evidence of coagulopathy
• Subjects who have a history of one or more of the following:
• hematuria (microscopic or gross)
• urinary tract neoplasia
• nephrolithiasis
• glomerulonephritis
• active urinary tract infection (UTI)
• Bleeding disorders within the past 6 weeks or vasculitis with diffused alveolar hemorrhage
• Diagnosis of bleeding peptic ulcer disease within the previous 2 months
• Congenital bleeding diatheses such as hemophilia
• Treatment with anti-platelet, anti-coagulant agents, or non-steroidal anti-inflammatory drugs (NSAIDs)within 72 hours following infusion of study drug
• Therapeutic heparin:

Where it is running

• University of Miami — Miami, Florida, United States
• Beth Israel Deconess Medical Center — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Akron General Medical Center — Akron, Ohio, United States
• Baylor School of Medicine — Houston, Texas, United States
• Capital Health — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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