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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05996835 | Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI) | PHASE2 | COMPLETED | 316 | — | — | Jan 18, 2024 | May 14, 2026 | Jun 1, 2026 | 79 | United States, Argentina +15 |
| NCT05507437 | Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury | PHASE2 | COMPLETED | 20 | — | — | Nov 22, 2022 | Apr 25, 2024 | Dec 4, 2025 | 7 | Belgium, France +3 |
The weighted average of area under the time-corrected endogenous creatinine clearance curve. Urine volume, urinary creatinine, and the serum creatinine measurements will be used for calculation. Day 1-8 measurements will be included.
Cmax is defined as the maximum (peak) observed concentration following a dose. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
AUClast is the area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of TIN816. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
The AUC from time zero to infinity (mass x time x volume-1). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
T1/2 is the elimination half-life associated with the terminal slope. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
CL is the total body clearance of TIN816 from the serum following intravenous administration (volume x time-1). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Vz is the apparent volume of distribution during terminal phase following intravenous administration. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
| Arm | Type | Description |
|---|---|---|
| TIN816 Dose A | EXPERIMENTAL | Administered as a one time intravenous dose |
| TIN816 Dose B | EXPERIMENTAL | Administered as a one time intravenous dose |
| TIN816 Dose C | EXPERIMENTAL | Administered as a one time intravenous dose |
| Placebo | PLACEBO_COMPARATOR | 0.9% sterile saline administered as a one time intravenous dose |
| TIN816 | EXPERIMENTAL | Administered as an intravenous dose |
| Name | Type | Description |
|---|---|---|
| TIN816 70 mg lyophilisate powder | BIOLOGICAL | Immunotherapy Recombinant human CD39 enzyme |
| Placebo | OTHER | 0.9% sterile saline solution |
Inclusion Criteria: 1. Signed informed consent must be obtained in accordance with local regulations. 2. ≥ 18 to ≤ 85 years of age 3. Admitted to ICU or intermediate care unit/ high dependency care unit (HDU) 4. Diagnosis of sepsis according to criteria defined by The Third International Consensus ...