A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 in Healthy Subjects and Subjects With Mildly Elevated LDL-C Levels

NCT07777003 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10582-102
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Dyslipidemia

Keywords

Elevated LDL-C；Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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

  From Screening until 10 days after last dose

Secondary Outcomes (5)

• LDL-C

  From baseline until 10 days after last dose

• PK parameter

  From baseline until 120 hours after last dose

• PK parameter

  From baseline until 120 hours after last dose

• PK parameter

  From baseline until 120 hours after last dose

• PK parameter

  From baseline until 120 hours after last dose

Study Arms (2)

HS-10582 group

EXPERIMENTAL

Drug: HS-10582

HS-10582 placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HS-10582 DRUG

Drug：HS-10582 Description：Subjects will receive HS-10582 orally as a single and multiple ascending dose.

HS-10582 group

Placebo DRUG

Drug：Placebo Description：Subjects will receive placebo matching the HS-10582 dose orally as a single and multiple ascending dose.

HS-10582 placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Haiyan Li, Director of Institution for Dr

CONTACT

010-68966677-8508; haiyanli1027@hotmail.com

Fangfang Wang

CONTACT

010-68966677-8508; doctorfancy@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 20, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-07