Measure:
Maximum Tolerated Dose (MTD) .
TimeFrame:
Day1
Description:
Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. In this study, DLT was defined as liver, kidney, heart and mental nervous system toxicity of level 2 or above or blood system toxicity of level 3 or above and other systemic adverse events occurred within 14 days after drug administration, and the adverse events were judged to be related to the experimental drug use.If more than 3 (including 3) DLT cases are present in any dose group, the test should be terminated. The previous dose of this dose is considered the maximum tolerated dose (MTD).
Measure:
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
TimeFrame:
Day1
Description:
Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. All adverse events were determined according to NCI CTCAE4.03.CTCAE4.03 was classified into grades 1 to 5, in which grade 1 was mild adverse event and grade 5 was death due to adverse event.
Measure:
The Cmax of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , Tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The Tmax of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , Tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The MRT of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , Tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The AUClast of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , Tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The AUC0-inf of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , Tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The t1/2 of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , Tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The VZ of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , Tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The CL of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , Tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The potential immunological reaction (antibody formation) of single ascending doses of rh-Tβ4.
TimeFrame:
Day 1ć14ć28.
Description:
Approximately 5mL venous blood was collected from subjects before, 14 days after, and 28 days after administration for ADA study of rh-Tβ4 in healthy subjects.After the 28th-day follow-up period, subjects who confirm that ADA results are positive should be reexamined every 30 days (±3 days) until the results turn negative or the titer level is stable for two consecutive times.