A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
IBI128 300mg po. QD(Quaque Die)
IBI128 25mg po. QD(Quaque Die)
IBI128 50mg po. QD(Quaque Die)
The First Affiliated
Zhengzhou, Henan, China
PK parameter: Cmax
Maximum plasma concentration(Cmax) of IBI128
Time frame: Up to Day 8
PK parameter: AUC
Area under the concentration-time curve (AUC)of IBI128
Time frame: Up to Day 8
PK parameter: Tmax
Time to ahieve Cmax
Time frame: Up to Day 8
PK parameter: T1/2
The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%.
Time frame: Up to Day 8
Safety parameter: AE
Number of subjects with Adverse Event
Time frame: Up to Day 8
PD parameter: serum UA (uric acid)
The Percentage change of serum UA assesed by Area Under Curve 24,Cmean,24,Cmean,24 of IBI128 from baseline.
Time frame: Up to Day 8
Tolerability parameter: SAE
Number of subjects with Serious Adverse Event
Time frame: Up to Day 8
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IBI128 200mg po. QD(Quaque Die)
IBI128 100mg po. QD(Quaque Die)