Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syn… (NCT01438853) | Clinical Trial Compass
CompletedPhase 1
Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
United States18 participantsStarted 2004-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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 \<8.0 g/dL
✕. Subjects who have any one of the following:
✕
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: Up to 4 weeks
2
Cmax
Timeframe: predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeks
3
AUCinf and AUClast
Timeframe: Up 163.3 hours
4
Terminal t1/2 and Tmax
Timeframe: predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeks
5
Vd and Vss
Timeframe: predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeks