DyslipidemiaPhase 1NCT07777003
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 study testing HS-10582 in people with Dyslipidemia, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- HS-10582
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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);
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- HS-10582, Placebo
- Keywords
- Elevated LDL-C；Hypercholesterolemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10582Drug
Drug：HS-10582 Description：Subjects will receive HS-10582 orally as a single and multiple ascending dose.
PlaceboDrug
Drug：Placebo Description：Subjects will receive placebo matching the HS-10582 dose orally as a single and multiple ascending dose.
| Study group | Role | What they receive |
|---|---|---|
| HS-10582 group | Experimental | Not described Receives: Drug: HS-10582 |
| HS-10582 placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Screening until 10 days after last dose
Secondary outcomes (5)
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
Measured: From baseline until 10 days after last dose
PK parameter
Tmax
Measured: From baseline until 120 hours after last dose
PK parameter
Cmax
Measured: From baseline until 120 hours after last dose
PK parameter
t1/2
Measured: From baseline until 120 hours after last dose
PK parameter
AUC
Measured: From baseline until 120 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777003
- Sponsor's protocol ID
- HS-10582-102
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07777003
- Acronym / sponsor ID
- HS-10582-102
- Conditions
- Dyslipidemia
- Keywords
- Elevated LDL-C；Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10582 group | Experimental | Drug: HS-10582 |
| HS-10582 placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10582Drug：HS-10582 Description：Subjects will receive HS-10582 orally as a single and multiple ascending dose. | Drug | HS-10582 group |
| PlaceboDrug：Placebo Description：Subjects will receive placebo matching the HS-10582 dose orally as a single and multiple ascending dose. | Drug | HS-10582 placebo group |
Primary outcome
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
5 secondary outcomes
LDL-C
Time frame: From baseline until 10 days after last dose
PK parameter
Time frame: From baseline until 120 hours after last dose
PK parameter
Time frame: From baseline until 120 hours after last dose
PK parameter
Time frame: From baseline until 120 hours after last dose
PK parameter
Time frame: From baseline until 120 hours after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10582 in people with Dyslipidemia, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Li, Director of Institution for Dr (010-68966677-8508, haiyanli1027@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Adverse Events (time frame: From Screening until 10 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.