This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10510 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.
This study will consist of three parts (Parts A，B and C). 32 subjects have been planned for Part A and up to 36 subjects for Part B and 20 subjects for Part C.
Healthy male and female subjects aged 18-55 years (inclusive) at the time of signing the informed consent form.
Agree to use highly effective contraception from the date of signing the informed consent to 30 days after the last dose.
Male or female subjects agree to avoid donating sperm or eggs from the date of signing the informed consent to 90 days after the last dose.
Female subjects of childbearing potential must have a negative blood pregnancy test within 3 days before dosing.
Subjects with clinically significant abnormalities in vital signs, physical examination, or laboratory test results during the screening period, as determined by the investigator (a single retest may be performed within the screening window if there is a clear reason for retesting, and the retest results will be used for screening).
Subjects who have undergone LDL apheresis or plasmapheresis within 12 months before screening.
Subjects who have donated or lost ≥400 mL of blood or received a blood transfusion or bone marrow donation within 3 months before screening; or donated or lost ≥200 mL of blood within 1 month before screening.
Subjects with clinically significant abnormalities in 12-lead ECG results at screening, as determined by the investigator (e.g., QTcF interval (Fridericia's formula) >450 msec for males, >470 msec for females; PR interval >200 msec, etc.).
8
Treatment groupsSee each treatment group below.