Ascending oral single-dose study to evaluate the safety and pharmacokinetics of TVB- 2640 tablets in the Chinese healthy population.
This study is designed as a single-center, randomized, single-blind, placebo-controlled, single-dose escalation trial. The dose groups are 25 mg, 50 mg and 75 mg respectively. The next dose should be tested only if the previous dose has demonstrated to be safe and tolerated, and each subject will receive either the experimental drug or a placebo only once.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
Hunan provincial people's hospital
Changsha, Hunan, China
Evaluation of the safety and tolerability of TVB-2640 in Chinese healthy volunteers: adverse events and serious adverse events
Evaluation of number of patients reported with adverse events and serious adverse events.
Time frame: Up to 4 days
Evaluate the Cmax of TVB-2640
Evaluate the Peak Plasma Concentration after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Time frame: Up to 3 days
Tmax of TVB-2640
Evaluate the Time to reach the maximum plasma concentration after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Time frame: Up to 3 days
AUC of TVB-2640
Evaluate the Area under the plasma concentration versus time curve after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Time frame: Up to 3 days
t1/2 of TVB-2640
Evaluate the Terminal-Phase Half-Life after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Time frame: Up to 3 days
CL/F of TVB-2640
Evaluate the Apparent Systemic Clearance after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Time frame: Up to 3 days
Vd/F of TVB-2640
Evaluate the Apparent Volume of Distribution after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Time frame: Up to 3 days
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