This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10582 following single and multiple dose administration to healthy subjects and subjects with Mildly Elevated LDL-C.
This study will consist of two parts: single ascending dose (SAD) and multiple ascending dose (MAD).
For all participants
Participants have a full understanding of the study content, process, and possible adverse reactions, are willing to complete the study in strict accordance with the study protocol, and voluntarily sign the ICF;
Participants must be 18 to 55 years of age (inclusive) at the time of signing the ICF;
Body mass index (BMI) between 19.0 and 32.0 kg/m2 (inclusive), with body weight not less than 50.0 kg for males and not less than 45.0 kg for females;
Participants with clinically significant abnormal vital signs, physical examination, or laboratory results as judged by the investigator during the screening period;
Pregnant or lactating women;
Any medication taken within 2 weeks or 5 half-lives (whichever is longer) before screening and any medication expected to be taken throughout the study, including prescription drugs, over-the-counter drugs, Chinese herbal medicine, and health products (except for medications used to treat AEs);
Participants with concomitant diseases that may significantly affect the absorption of drugs or nutrients as judged by the investigator, such as clinically significant gastrointestinal diseases (e.g., active inflammatory bowel disease) and symptoms of gastrointestinal disorders; or any condition that may affect the absorption of drugs, such as partial or total gastrectomy, gastric bypass, and resection of any intestinal area;
Sequential
HS-10582
DrugDrug：HS-10582 Description：Subjects will receive HS-10582 orally as a single and multiple ascending dose.
Placebo
DrugDrug：Placebo Description：Subjects will receive placebo matching the HS-10582 dose orally as a single and multiple ascending dose.
Number of subjects with Adverse Events
The safety and tolerability of HS-10582 following oral administration of single ascending doses and multiple ascending doses will be assessed
LDL-C
The pharmacodynamics (PD) of HS-10582 by assessment of LDL-C following oral administration of single ascending doses and multiple ascending doses will be assessed
PK parameter
Tmax
PK parameter
Cmax
PK parameter
t1/2
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