Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01438853 | Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome | PHASE1 | COMPLETED | 18 | — | — | Dec 1, 2004 | Feb 1, 2008 | Jan 6, 2025 | 7 | United States, Canada |
To evaluate the safety of escalating dose levels of TNX-832 in subjects with suspected or proven bacteria-induced ALI/ARDS. Safety was assessed by number of treatment emergent adverse events, and changes in vital signs, ECGs, laboratory, coagulation and pulmonary function parameters from baseline. Immunogenicity (serum anti-TNX-832 antibody response) was evalutated.
maximum observed concentration (Cmax)
Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf). AUClast (area under the serum concentration-time curve from the time of dosing to the time of the last observed concentration).
t1/2 (terminal elimination phase half life). Tmax (time to maximum serum concentration).
Volume of distribution (Vd) based on the terminal elimination phase, also referred to as VZ; in mL/kg. Volume of distribution at steady state (Vss), calculated as the Mean residence Time times Clearance; in mL/kg.
Total body clearance, CL=Dose/AUC; in mL/hr/kg
| Arm | Type | Description |
|---|---|---|
| TNX-832 | EXPERIMENTAL | Anti-tissue factor antibody |
| Drug Placebo | PLACEBO_COMPARATOR | Placebo control |
| Name | Type | Description |
|---|---|---|
| TNX-832 | BIOLOGICAL | Single intravenous dose of TNX-832 at 0.06, 0.08 or 0.10 mg/kg |
| Placebo | DRUG | Single intravenous dose of saline control |
Inclusion Criteria: 1. ≥ 18 years 2. Suspected or proven bacterial infection 3. Receiving positive pressure ventilation through an endotracheal tube 4. Have ALI/ARDS, defined as having all of the following: * bilateral infiltrates consistent with pulmonary edema * Hypoxemia * no clinical ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | — | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | — | Undisclosed |
| Danaher Corporation | DHR | 3 | — | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | NA | Undisclosed |