The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Oral tablets
Oral tablets
Hunan provincial people's hospital
Changsha, Hunan, China
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 28 days
Time frame: Up to 28 days
AUC of ASC41
Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.
Time frame: Up to 28 days
Cmax of ASC41
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.
Time frame: Up to 28 days
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.
Time frame: Up to 28 days
CL/F of ASC41
Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Time frame: Up to 28 days
Vd/F of ASC41
Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Time frame: Up to 28 days
Tmax of ASC41
Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.
Time frame: Up to 28 days
LDL-C and other lipid parameters
To evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) .
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Time frame: Up to 28 days