Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TIN816 lyophilisate · 2 trials · 1 indication
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 ...
TIN816 lyophilisate is an investigational monoclonal antibody developed by Novartis AG for acute kidney injury due to sepsis. It is a lyophilised powder formulation given to adult patients. The program has completed two Phase 2 clinical trials in this indication, and the drug has not been approved for commercial use.
TIN816 lyophilisate is being studied for the treatment of acute kidney injury due to sepsis, a serious kidney complication that develops in patients with sepsis. Both completed clinical trials enrolled adults aged 18 years and older with this condition. It remains investigational and is not an approved therapy.
TIN816 lyophilisate is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the monoclonal antibody in sepsis-associated acute kidney injury.
TIN816 lyophilisate is in Phase 2 development. Two Phase 2 trials have been completed, including the Phase 2b CLEAR-AKI study, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulator.
TIN816 lyophilisate has been evaluated in two completed Phase 2 trials: NCT05996835, the Phase 2b CLEAR-AKI study, which enrolled 316 patients across 17 countries, and NCT05507437, a pharmacokinetics and safety study that enrolled 20 patients. Both were randomized, double-blind, and placebo-controlled.