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Not yet recruitingNCT07777003Updated Aug 20, 2026

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

A Phase 1 interventional study of HS-10582 and Placebo in Dyslipidemia, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Dyslipidemia

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Keywords

  • Elevated LDL-C;Hypercholesterolemia
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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);
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    HS-10582 group

    Drug: HS-10582

  • Placebo comparator
    HS-10582 placebo group

    Drug: Placebo

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.

05

What researchers measure

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

    Time frame: From Screening until 10 days after last dose

Secondary outcomes

  1. 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

    Time frame: From baseline until 10 days after last dose

  2. PK parameter

    Tmax

    Time frame: From baseline until 120 hours after last dose

  3. PK parameter

    Cmax

    Time frame: From baseline until 120 hours after last dose

  4. PK parameter

    t1/2

    Time frame: From baseline until 120 hours after last dose

  5. PK parameter

    AUC

    Time frame: From baseline until 120 hours after last dose

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07777003
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
May 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Haiyan Li, Director of Institution for Dr
Contact
haiyanli1027@hotmail.com
010-68966677-8508
Fangfang Wang
Contact
doctorfancy@126.com
010-68966677-8508

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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