The objective of this study is to compare the pharmacokinetic parameters of ASC41 in healthy subjects after single and multiple oral dosing.
The purpose of this study was to evaluate the tolerability, safety pharmacokinetics and pharmacodynamic (biomarkers) of ASC41 tables in a randomized, double-blind, placebo-controlled single- and multiple-dose phase I clinical trial in healthy subjects the study. The effects of ASC41 on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) will be observed after repeated administration of ASC41 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
ASC41,1mg/table;5mg/table
ASC41 placebo,1mg/table;5mg/table
Hunan provincial people's hospital
Changsha, Hunan, China
Evaluation of the safety and tolerability of ASC41 in healthy volunteers
Evaluation of the safety and tolerability of ASC41 in healthy volunteers
Time frame: Up to 32 days
Cmax of ASC41
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
Tmax of ASC41
Evaluate the Time to reach the maximum plasma concentration after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
AUC of ASC41
Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers volunteers.
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
CL/F of ASC41
Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC41 administered to Chinese healthy volunteers.
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Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
Vd/F of ASC41
Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC41 administered to Chinese healthy volunteers.
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.