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NCT Number: NCT07777003

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

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).

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

HS-10582

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of subjects with Adverse Events

    Time frame: 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 outcomes

  1. LDL-C

    Time frame: 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

  2. PK parameter

    Time frame: From baseline until 120 hours after last dose

    Tmax

  3. PK parameter

    Time frame: From baseline until 120 hours after last dose

    Cmax

  4. PK parameter

    Time frame: From baseline until 120 hours after last dose

    t1/2

  5. PK parameter

    Time frame: From baseline until 120 hours after last dose

    AUC

Study contacts

Contact information is provided by the study sponsor or research team.

Fangfang Wang

CONTACT

[email protected]

010-68966677-8508

Haiyan Li, Director of Institution for Dr

CONTACT

[email protected]

010-68966677-8508

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 Tablets After Single and Multiple Oral Doses in Healthy Subjects and Subjects With Mildly Elevated LDL-C

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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