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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. (part of Hansoh Pharmaceutical Group Company Limited) · 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

In context

Dyslipidemias

1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.

This study's planned enrollment of 76 is below the median of 100 across 986 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 137 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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;
  • (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 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/ 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 drug (whichever is longer, except for those who have not received the investigational drug or device);
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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.

06

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.

Of 77 industry-sponsored phase 1 interventional studies under Dyslipidemias, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 8. This study's planned 8 months is above that.

Counting every sponsor, half of 83 studies reached it within 2 months; a quarter within 1 and three quarters within 10.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2026
First posted
Aug 20, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
May 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07777003
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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