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 being developed for acute kidney injury due to sepsis. It is administered as a lyophilisate, a freeze-dried formulation. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
TIN816 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its potential to address acute kidney injury caused by sepsis, though the exact mechanism of action is not publicly detailed.
TIN816 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of TIN816 in patients with sepsis-associated acute kidney injury.
TIN816 is in Phase 2 clinical development. Two Phase 2 trials have been completed, including a pharmacokinetics and safety study and a larger Phase 2b efficacy study. The drug remains investigational and is not yet approved for any use.
TIN816 has been studied in two completed Phase 2 trials. NCT05507437 evaluated pharmacokinetics and safety in 20 patients across five European countries. NCT05996835, the CLEAR-AKI study, investigated safety and efficacy in 316 patients across multiple countries including the United States, China, and Japan.
No alternative names for TIN816 have been identified in the available clinical trial information. The drug is consistently referred to as TIN816 in trial registrations and is being developed solely by Novartis for sepsis-associated acute kidney injury.