CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
TNX-832 +1 morebiological
Likely dose
TNX-832 0.10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01438853
NCT01438853Phase 1Completed
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The Safety, Pharmacokinetics, and Pharmacodynamic Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome

Altor BioScience·interventional·Posted Sep 22, 2011·Updated Jan 6, 2025

In Brief

A Phase 1 clinical trial evaluating TNX-832 and Placebo for Sepsis and 2 related conditions. Completed, enrolled 18 participants across 7 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis, Acute Lung Injury, Acute Respiratory Distress Syndrome
CountriesCanada, United States
CollaboratorsGenentech, Inc., Tanox

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2011
Enrollment StartDec 1, 2004
Primary CompletionJul 1, 2006
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.8 years ago

Interventions

TNX-832biological

Single intravenous dose of TNX-832 at 0.06, 0.08 or 0.10 mg/kg

Placebodrug

Single intravenous dose of saline control