to evaluate the pharmacokinetics, and pharmacodynamics of a single dose of Tai Ai injection in healthy adult Chinese subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
The patient received one treatment of RC18 80mg in the test group
The patient received one treatment of RC18 160mg in the test group
The patient received one treatment of RC18 240mg in the test group
Remegen,ltd.
Yantai, Shandong, China
C-max
Maximum observed plasma concentration
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
T-max
Time to reach maximum observed plasma concentration
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
T1/2
apparent terminal half-life
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
AUC0-t
area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
AUC0-∞
Area under the plasma concentration-time curve from time 0 extrapolated to infinity
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of AEs (adverse events).Through observing number of total AEs and number of subjects with AEs and other factors of AEs ,to evaluate the safety and tolerance of healthy subjects.
Occurrence of all adverse events from signing of informed consent through end of study treatment.
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of Vital Signs
Through observing the normal and abnormal conditions of axillary temperature to evaluate the safety and tolerance of healthy subjects. Axillary temperature's normal :≥36 and ≤37°C. Clinical significance of abnormal values as judged by the investigator
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Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of Vital Signs
Through observing the normal and abnormal conditions of Pulse rate to evaluate the safety and tolerance of healthy subjects. Pulse rate's normal :≥60 and ≤100. Clinical significance of abnormal values as judged by the investigator
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of Vital Signs
Through observing the normal and abnormal conditions of Blood pressure (both systolic and diastolic) to evaluate the safety and tolerance of healthy subjects. systolic pressure 's normal: ≥90 and ≤139 ; diastolic pressure's normal :≥60 and ≤89. Clinical significance of abnormal values as judged by the investigator
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of Vital Signs
Through observing the normal and abnormal conditions of respiration to evaluate the safety and tolerance of healthy subjects. respiration's normal :≥10 and ≤24. Clinical significance of abnormal values as judged by the investigator
Time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57