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

NCT01438853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-01-06

Study results available
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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.

Conditions

  • Sepsis
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome

Interventions

BIOLOGICAL

TNX-832

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

DRUG

Placebo

Single intravenous dose of saline control

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Tanox

    collaborator INDUSTRY

  • Altor BioScience

    lead INDUSTRY

Principal Investigators

  • Hing Wong, PhD · Altor BioScience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-07-31
Completion
2008-02-29

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438853 on ClinicalTrials.gov