This study was divided into three parts: single and multiple dosing and food effect study, which were designed to evaluate the safety and tolerability of TQH3906 capsules administered in single or multiple dose escalation in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
TQH3906 is a kinase inhibitor.
Placebo Comparator
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Adverse events (AE)
Incidence of adverse events (AE)
Time frame: Up to 18 days
Serious Adverse Events (SAE)
Incidence of serious adverse events (SAE)
Time frame: Up to 18 days
Treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 18 days
Time to peak concentration (Tmax)
The time it takes to reach the peak concentration
Time frame: Up to 18 days
Peak concentration (Cmax)
Maximum plasma drug concentration
Time frame: Up to 18 days
Area under the blood concentration-time curve
The amount of drug absorbed into the circulation after administration of a single dose can be estimated from the area under the blood concentration-time curve, with Auc in units of concentration \* time.
Time frame: Up to 18 days
Apparent volume of distribution (Vd/F)
It is the ratio of the amount of drug in the body to the blood concentration of the drug when the drug reaches dynamic equilibrium in the body is called the apparent volume of distribution.
Time frame: Up to 18 days
Plasma clearance (CL/F)
It is the sum of drug clearance by the liver and kidneys, etc., i.e., how many volumes of plasma are cleared of drug per unit of time in L/h, or L/(kg-h) if calculated on the basis of body weight.
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Time frame: Up to 18 days
Plasma elimination half-life (t1/2)
The time required for the concentration of a drug in the blood or the amount of drug in the body to be reduced to 1/2. The time required for absorption, distribution and elimination of half the amount of drug (or blood concentration) in the body becomes the absorption half-life, distribution half-life and elimination half-life, respectively.
Time frame: Up to 18 days
Steady-state peaking time (Tmax, ss)
The time required to reach a steady-state peak concentration after administration.
Time frame: Up to 18 days
Steady state peak concentration (Cmax, ss)
The steady-state blood drug concentration is a serrated plasma drug concentration curve, with the highest steady-state blood drug concentration being the peak steady-state blood drug concentration.
Time frame: Up to 18 days
Steady state valley concentration (Cmin, ss)
The steady-state blood drug concentration is a serrated plasma drug concentration curve, with the lowest steady-state blood drug concentration being the trough of the steady-state blood drug concentration.
Time frame: Up to 18 days
Average steady-state blood drug concentration (Cav, ss)
The average concentration reached when the drug concentration reaches a steady state after a continuous given dose of medication.
Time frame: Up to 18 days
Area under steady-state blood drug concentration time curve (AUC0- τ)
After a single dose administration, the amount of medication absorbed into the human bloodstream can be estimated using the area under the blood drug concentration time curve, with the unit of Auc being concentration \* time.
Time frame: Up to 18 days
Accumulation ratio (Rac)
The ratio of the required dose for a single administration to the total dose required for a split administration.
Time frame: Up to 18 days
Renal clearance rate (CLr/F)
The ability of both kidneys to completely remove a substance equivalent to several milliliters of plasma within one minute.
Time frame: Up to 18 days
INF-γ release
Inhibition efficiency of INF-γ release by TQH3906 in IL-12/IL-18-stimulated peripheral blood mononuclear cells from subjects.
Time frame: Up to 18 days
QTcF interval
Effect of TQH3906 on the QTcF interval in healthy subjects.
Time frame: Up to 18 days