The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
Zhejing Provincial People's Hospital
Hangzhou, Zhejiang, China
Number of subjects with adverse events and serious adverse events.
Time frame: Pre-dose to 7 days after multiple dose administration.
PK parameter will be evaluated.
Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration
Maximum observed serum concentration (Cmax) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration
Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration
Apparent total clearance of the drug from plasma after oral administration (CL/F) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration.
Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285
Time frame: Pre-dose to 3 days after single dose administration.
Time to elimination half-life (T1/2) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration
Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration
Steady-state peak concentration (Cmax,ss) for multiple dose of SHR2285.
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Time frame: Pre-dose to 2 days after multiple dose administration
Steady state valley concentration (Ctrough,ss) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration
Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
Time to elimination half-life (T1/2) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration
Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
Accumulation ratio (Racc) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
Percentage of fluctuation (PTF%) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
PD parameter will be evaluated.
FXI activity; Change of APTT, PT, INR from baseline.
Time frame: Pre-dose to 3 days after single dose administration.
PD parameter will be evaluated.
FXI activity; Change of APTT, PT, INR from baseline.
Time frame: Pre-dose to 2 days after multiple dose administration.