Dyslipidemia
Conditions
Keywords
Elevated LDL-C；Hypercholesterolemia
Brief summary
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).
Interventions
DRUGHS-10582
Drug：HS-10582 Description：Subjects will receive HS-10582 orally as a single and multiple ascending dose.
DRUGPlacebo
Drug：Placebo Description：Subjects will receive placebo matching the HS-10582 dose orally as a single and multiple ascending dose.
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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;
Exclusion criteria
* 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; * Those who should not be enrolled per the investigator's opinion. * History of severe allergic/hypersensitivity reactions or persistent clinically significant allergic/hypersensitivity reactions, or history of hypersensitivity reactions to drugs with a chemical structure similar to HS-10582 as judged by the investigator; * Have participated in clinical studies of any drug or medical device and received at least one treatment (including placebo) within 12 weeks before screening, or are still within 5 half-lives of the investigational drug (whichever is longer, except for those who have not received the investigational drug or device);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Adverse Events | From Screening until 10 days after last dose | The safety and tolerability of HS-10582 following oral administration of single ascending doses and multiple ascending doses will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C | From baseline until 10 days after last dose | 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 | From baseline until 120 hours after last dose | Tmax |
Contacts
CONTACTHaiyan Li, Director of Institution for Dr
CONTACTFangfang Wang
Outcome results
None listed