DyslipidemiaPhase 1NCT07001787
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10510 in Healthy Subjects
A Phase 1 study testing Drug：HS-10510； and Drug： Rosuvastatin 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-10510 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels. This study will consist of three parts (Parts A，B and 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?
- Drug：HS-10510； and Drug： Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Mar 2026
- 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
- Healthy male and female subjects aged 18-55 years (inclusive) at the time of signing the informed consent form.
- Agree to use highly effective contraception from the date of signing the informed consent to 30 days after the last dose.
- Male or female subjects agree to avoid donating sperm or eggs from the date of signing the informed consent to 90 days after the last dose.
- Female subjects of childbearing potential must have a negative blood pregnancy test within 3 days before dosing.
- Based on the medical history, physical examination, vital signs (VS) measurements, and ECG and safety test results conducted during the screening visit and before randomization, the subject is in good health.
- The subject has a full understanding of the trial content, process, and potential adverse reactions, is willing to strictly adhere to the trial protocol to complete this study, and voluntarily signs the informed consent form.
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- No more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits, 125 mL of wine) in a single session within two weeks before screening; no alcohol (including alcohol-containing products) 48 hours before dosing and throughout the study period.
- No smoking 48 hours before dosing and throughout the study period.
- No more than 6 cups (approximately 250 mL per cup) of coffee, tea, cola, or other caffeine-containing beverages on average per day within three months before screening; no xanthine- or caffeine-containing foods or beverages throughout the study period.
- Maintain a stable diet and exercise lifestyle throughout the study period; avoid all activities that may cause injury or intense physical activity.
- Agree to avoid consuming grapefruit, grapefruit juice, bitter orange, bitter orange juice, or other products containing grapefruit or bitter orange, mulberry juice, cruciferous vegetables (such as kale, watercress, Chinese broccoli, Brussels sprouts, and mustard greens), or grilled meats from 7 days before dosing to the end of the last visit.
- For Part A
- BMI between 19.0-28.0 kg/m2 (inclusive), with a minimum weight of 50.0 kg for males and 45.0 kg for females.
- For Part B
- Fasting LDL-C between 1.8-4.9 mmol/L (inclusive) at screening.
- Fasting triglycerides ≤4.52 mmol/L at screening.
- BMI between 20.0-35.0 kg/m2 (inclusive), with a minimum weight of 50.0 kg for males and 45.0 kg for females.
- For Part C
- Fasting LDL-C between 2.6-4.9 mmol/L (inclusive) at screening.
- Fasting triglycerides ≤4.52 mmol/L at screening.
- BMI between 20.0-35.0 kg/m2 (inclusive), with a minimum weight of 50.0 kg for males and 45.0 kg for females.
- LDL-C reduction of ≥30% after a 28-day rosuvastatin run-in period.
Who cannot join
- Subjects with clinically significant abnormalities in vital signs, physical examination, or laboratory test results during the screening period, as determined by the investigator (a single retest may be performed within the screening window if there is a clear reason for retesting, and the retest results will be used for screening).
- Subjects who have undergone LDL apheresis or plasmapheresis within 12 months before screening.
- Subjects who have donated or lost ≥400 mL of blood or received a blood transfusion or bone marrow donation within 3 months before screening; or donated or lost ≥200 mL of blood within 1 month before screening.
- Subjects with clinically significant abnormalities in 12-lead ECG results at screening, as determined by the investigator (e.g., QTcF interval (Fridericia's formula) >450 msec for males, >470 msec for females; PR interval >200 msec, etc.).
- Subjects with systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg at screening.
- Subjects with alanine aminotransferase (ALT) >1.5×ULN, aspartate aminotransferase (AST) >1.5×ULN, or total bilirubin (TBIL) >1×ULN at screening.
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- Pregnant or breastfeeding females.
- Subjects who have undergone major surgery within 3 months before screening or plan to undergo surgery during the study period.
- Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis serospecific antibody (TP-Ab).
- Subjects who are heavy smokers or have smoked an average of 5 or more cigarettes per day within 3 months before screening.
- Subjects with difficulty in venous blood collection or who experience fainting or dizziness during blood collection.
- Subjects who have taken any medication, including prescription drugs, over-the-counter drugs, herbal medicines, or dietary supplements, within 2 weeks or 5 half-lives (whichever is longer) before screening, and are expected to take any medication during the study period (except for the rosuvastatin treatment in Part C) (excluding treatment for adverse events).
- Subjects with diseases or conditions that, as determined by the investigator, could significantly affect the absorption of drugs or nutrients, such as clinically significant gastrointestinal diseases (e.g., active inflammatory bowel disease) or symptoms of gastrointestinal disorders; or any condition that could affect drug absorption, such as subtotal or total gastrectomy, gastric bypass, or any bowel resection.
- Subjects whom the investigator deems ineligible.
- Subjects with the following diseases or medical history before screening or before randomization:
- Subjects with a history of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, or a history of hypersensitivity to drugs with a chemical structure similar to HS-10510, as determined by the investigator.
- Subjects with a history of endocrine diseases that could significantly affect body weight, such as diabetes, Cushing's syndrome, hypothyroidism, or hyperthyroidism.
- Subjects with a history of moderate to severe depression or a history of severe psychiatric disorders, such as schizophrenia or bipolar disorder.
- Subjects with a history of acute or chronic hepatitis or other severe liver diseases, except for non-alcoholic fatty liver disease.
- Subjects with a history of severe cardiovascular disease within 6 months before screening, including decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, acute myocardial infarction, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention.
- Subjects with a history of or current severe infection, such as cellulitis, pneumonia, or sepsis, within 30 days before screening.
- Subjects with a history of drug abuse or illicit drug use within 1 year before screening, or positive results on urine drug screening.
- Subjects with a history of alcoholism or who have consumed more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits (≥35% alcohol), 150 mL of wine) in a single session within 2 weeks before screening, or positive results on alcohol breath testing at screening.
- Subjects with a history of malignant tumors.
- Subjects who have received or plan to receive live (attenuated) vaccines within 12 weeks before screening.
- Subjects with concurrent cardiovascular, liver, kidney, gastrointestinal, psychiatric, neurological, hematological, or metabolic disorders.
- Subjects who have used any of the following medications or treatments before screening:
- Subjects who have used medications that could affect cholesterol levels (e.g., statins, ezetimibe, niacin, and supplements such as ω-3 fatty acids) within 8 weeks before screening.
- Subjects who are currently or have previously received inclisiran sodium or other investigational siRNA PCSK9 inhibitors.
- Subjects who have received PCSK9 inhibition (approved or investigational) treatment within 12 months before screening.
- Subjects who have received microsomal triglyceride transfer protein inhibitors (e.g., lomitapide) within 12 months before screening.
- Subjects who have received systemic steroid therapy, immunomodulatory therapy, or chemotherapy within 3 months before screening, or who may receive these treatments during the study period.
- Subjects who are currently receiving or have received medications known to prolong the QT interval (refer to the package insert) within 14 days before screening.
- Subjects with any of the following conditions:
- Subjects who have participated in any drug or medical device clinical trial 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, excluding those who did not receive the investigational drug or device).
- Subjects who are strict vegetarians or have medical dietary restrictions.
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 Phase I, Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability，Pharmacokinetics, and Pharmacodynamics of HS-10510 Following Single and Multiple Ascending Dose Administration to Healthy Subjects With or Without Elevated LDL-C Levels
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10510 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.
This study will consist of three parts (Parts A，B and C). 32 subjects have been planned for Part A and up to 36 subjects for Part B and 20 subjects for Part C.
Read the detailed description
This is a Phase I, First In Human (FIH), randomized, double-blind, placebo-controlled, study in Chinese healthy male and female subjects at one center. 32 subjects have been planned for Part A and up to 36 subjects for Part B and 20 subjects for Part C.
- Part A（SAD cohort）: A Screening Period of maximum 28 days. Admission to study center (Day -1). A Treatment Period (Day 1 to Day 4) with a single dose of HS-10510 or placebo on Day 1. Subjects will be discharged on Day 4. A Follow-up Visit within 7 days after the Investigational Medicinal Product (IMP) dose for all cohorts. (i) Part A1 - Up to 4 dose cohorts of HS-10510 are planned to be investigated. Within each cohort, 6 subjects will be randomized to receive HS-10510, and 2 subjects randomized to receive placebo. (ii) Part A2 - The subjects from a chosen cohort in Part A1 will stay at study center for 7 days to wash out after the first dose administration of IMP and will receive HS-10510 or placebo after intake of a high-calorie, high-fat breakfast, to assess the effect of food on the PK of HS-10510. The subjects will stay at the study center until 72 hours post-dose in both the parts.
- Part B（MAD cohort）: Up to 3 dose cohorts are planned to be investigated. In each cohort, 12 subjects will participate and receive either HS-10510 or placebo, randomized 3:1 for 28 days dosing.
- Part C（Rosuvastatin MAD cohorts）：20 subjects in this cohort will receive either HS-10510 in combination with rosuvastatin (10 subjects) or placebo in combination with rosuvastatin (10 subjects). Subjects eligible for these cohorts will begin a Screening period of 28 days, a rosuvastatin run-in period of 28 days, Treatment period of 28 days for this cohort and one Follow-up visits (1 week after last dose of IMP).
- Conditions
- Dyslipidemia
- Being tested
- Drug：HS-10510；, Drug：Placebo, Drug： Rosuvastatin
- 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.
Drug：HS-10510；Drug
Drug：HS-10510 Description：Subjects will receive HS-10510 orally as a single and multiple ascending dose.
Drug：PlaceboDrug
Drug：Placebo Description：Subjects will receive placebo matching the HS-10510 dose orally as a single and multiple ascending dose.
Drug： RosuvastatinDrug
Drug：Rosuvastatin Description：Subjects will receive rosuvastatin orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A-HS-10510 dose 1/placebo | Active comparator | A total of 6 subjects will receive single ascending doses of HS-10510 and 2 will receive placebo Receives: Drug: Drug：HS-10510；; Drug: Drug：Placebo |
| Part A-HS-10510 dose 2/placebo | Active comparator | A total of 6 subjects will receive single ascending doses of HS-10510 and 2 will receive placebo Receives: Drug: Drug：HS-10510；; Drug: Drug：Placebo |
| Part A-S-10510 dose 3/placebo | Active comparator | A total of 6 subjects will receive single ascending doses of HS-10510 and 2 will receive placebo Receives: Drug: Drug：HS-10510；; Drug: Drug：Placebo |
| Part A-HS-10510 dose 4/placebo | Active comparator | A total of 6 subjects will receive single ascending doses of HS-10510 and 2 will receive placebo Receives: Drug: Drug：HS-10510；; Drug: Drug：Placebo |
| Part B-HS-10510 dose 1/placebo | Active comparator | A total of 9 subjects will receive multiple ascending doses of HS-10510 and 3 will receive placebo Receives: Drug: Drug：HS-10510；; Drug: Drug：Placebo |
| Part B-HS-10510 dose 2/placebo | Active comparator | A total of 9 subjects will receive multiple ascending doses of HS-10510 and 3 will receive placebo Receives: Drug: Drug：HS-10510；; Drug: Drug：Placebo |
| Part B-HS-10510 dose 3/placebo | Active comparator | A total of 9 subjects will receive multiple ascending doses of HS-10510 and 3 will receive placebo Receives: Drug: Drug：HS-10510；; Drug: Drug：Placebo |
| Part C-HS-10510/Placebo with rosuvastatin | Active comparator | A total of 10 subjects will receive HS-10510 in combination with rosuvastatin and 10 subjects will receive placebo in combination with rosuvastatin Receives: Drug: Drug：HS-10510；; Drug: Drug：Placebo; Drug: Drug： Rosuvastatin |
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-10510 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B and C) will be assessed.
Measured: From Screening until Follow-up Visit (7 days post-dose for all cohorts)
Secondary outcomes (10)
LDL-C
The pharmacodynamics (PD) of HS-10510 by assessment of LDL-C following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B and C) will be assessed.
Measured: SAD cohorts: Days 1,2,3,4,8 Food Effect SAD cohort: Day 1,2,3,4,8,9,10,11,15 MAD cohorts: Days1,2,3,4,7,11,15,22,26,28,31,35 Rosuvastatin MAD Cohorts: Days1,2,3,4,7,11,15,22,26,28,31,35
Proprotein convertase subtilisin/kexin type 9(PCSK9)
The PD of HS-10510 by assessment of PCSK9 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B and C) will be assessed.
Measured: SAD cohorts: Days 1,2,3,8 Food Effect SAD cohort: Day 1,2,3,8,9,10,15 MAD cohorts: Days 1,2,3,7,11,15,22,28,31,35 Rosuvastatin MAD Cohorts: Days 1,2,3,7,11,15,22,28,31,35
HS-10510 PK parameter: Maximum observed plasma concentration (Cmax)
To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.
Measured: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Area under plasma concentration-time curve from zero to infinity (AUC0-inf)
To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.
Measured: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUC0-last)
To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.
Measured: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Area under the plasma concentration-curve across the dosing interval (AUC0-tau)
To characterise the steady state PK of HS-10510 following oral multiple administration of HS-10510.
Measured: MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Time to reach maximum observed concentration (Tmax)
To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.
Measured: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Terminal elimination half-life (t½)
To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.
Measured: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Apparent total body clearance (CL/F)
To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.
Measured: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
To characterise the single dose and steady state PK of HS-10510 following oral administration of HS-10510.
Measured: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (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
- 88 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
- NCT07001787
- Sponsor's protocol ID
- HS-10510-101
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 3 Jun 2025
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability，Pharmacokinetics, and Pharmacodynamics of HS-10510 Following Single and Multiple Ascending Dose Administration to Healthy Subjects With or Without Elevated LDL-C Levels
- ClinicalTrials.gov ID
- NCT07001787
- Acronym / sponsor ID
- HS-10510-101
- Conditions
- Dyslipidemia
- Keywords
- Elevated LDL-C；Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 3 Jun 2025 (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-10510 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.
This study will consist of three parts (Parts A，B and C). 32 subjects have been planned for Part A and up to 36 subjects for Part B and 20 subjects for Part C.
Detailed description
This is a Phase I, First In Human (FIH), randomized, double-blind, placebo-controlled, study in Chinese healthy male and female subjects at one center. 32 subjects have been planned for Part A and up to 36 subjects for Part B and 20 subjects for Part C.
- Part A（SAD cohort）: A Screening Period of maximum 28 days. Admission to study center (Day -1). A Treatment Period (Day 1 to Day 4) with a single dose of HS-10510 or placebo on Day 1. Subjects will be discharged on Day 4. A Follow-up Visit within 7 days after the Investigational Medicinal Product (IMP) dose for all cohorts. (i) Part A1 - Up to 4 dose cohorts of HS-10510 are planned to be investigated. Within each cohort, 6 subjects will be randomized to receive HS-10510, and 2 subjects randomized to receive placebo. (ii) Part A2 - The subjects from a chosen cohort in Part A1 will stay at study center for 7 days to wash out after the first dose administration of IMP and will receive HS-10510 or placebo after intake of a high-calorie, high-fat breakfast, to assess the effect of food on the PK of HS-10510. The subjects will stay at the study center until 72 hours post-dose in both the parts.
- Part B（MAD cohort）: Up to 3 dose cohorts are planned to be investigated. In each cohort, 12 subjects will participate and receive either HS-10510 or placebo, randomized 3:1 for 28 days dosing.
- Part C（Rosuvastatin MAD cohorts）：20 subjects in this cohort will receive either HS-10510 in combination with rosuvastatin (10 subjects) or placebo in combination with rosuvastatin (10 subjects). Subjects eligible for these cohorts will begin a Screening period of 28 days, a rosuvastatin run-in period of 28 days, Treatment period of 28 days for this cohort and one Follow-up visits (1 week after last dose of IMP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A-HS-10510 dose 1/placebo | Active comparator | Drug: Drug：HS-10510；, Drug: Drug：PlaceboA total of 6 subjects will receive single ascending doses of HS-10510 and 2 will receive placebo |
| Part A-HS-10510 dose 2/placebo | Active comparator | Drug: Drug：HS-10510；, Drug: Drug：PlaceboA total of 6 subjects will receive single ascending doses of HS-10510 and 2 will receive placebo |
| Part A-S-10510 dose 3/placebo | Active comparator | Drug: Drug：HS-10510；, Drug: Drug：PlaceboA total of 6 subjects will receive single ascending doses of HS-10510 and 2 will receive placebo |
| Part A-HS-10510 dose 4/placebo | Active comparator | Drug: Drug：HS-10510；, Drug: Drug：PlaceboA total of 6 subjects will receive single ascending doses of HS-10510 and 2 will receive placebo |
| Part B-HS-10510 dose 1/placebo | Active comparator | Drug: Drug：HS-10510；, Drug: Drug：PlaceboA total of 9 subjects will receive multiple ascending doses of HS-10510 and 3 will receive placebo |
| Part B-HS-10510 dose 2/placebo | Active comparator | Drug: Drug：HS-10510；, Drug: Drug：PlaceboA total of 9 subjects will receive multiple ascending doses of HS-10510 and 3 will receive placebo |
| Part B-HS-10510 dose 3/placebo | Active comparator | Drug: Drug：HS-10510；, Drug: Drug：PlaceboA total of 9 subjects will receive multiple ascending doses of HS-10510 and 3 will receive placebo |
| Part C-HS-10510/Placebo with rosuvastatin | Active comparator | Drug: Drug：HS-10510；, Drug: Drug：Placebo, Drug: Drug： RosuvastatinA total of 10 subjects will receive HS-10510 in combination with rosuvastatin and 10 subjects will receive placebo in combination with rosuvastatin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Healthy male and female subjects aged 18-55 years (inclusive) at the time of signing the informed consent form.
- Agree to use highly effective contraception from the date of signing the informed consent to 30 days after the last dose.
- Male or female subjects agree to avoid donating sperm or eggs from the date of signing the informed consent to 90 days after the last dose.
- Female subjects of childbearing potential must have a negative blood pregnancy test within 3 days before dosing.
- Based on the medical history, physical examination, vital signs (VS) measurements, and ECG and safety test results conducted during the screening visit and before randomization, the subject is in good health.
Key exclusion criteria (36 listed)
- Subjects with clinically significant abnormalities in vital signs, physical examination, or laboratory test results during the screening period, as determined by the investigator (a single retest may be performed within the screening window if there is a clear reason for retesting, and the retest results will be used for screening).
- Subjects who have undergone LDL apheresis or plasmapheresis within 12 months before screening.
- Subjects who have donated or lost ≥400 mL of blood or received a blood transfusion or bone marrow donation within 3 months before screening; or donated or lost ≥200 mL of blood within 1 month before screening.
- Subjects with clinically significant abnormalities in 12-lead ECG results at screening, as determined by the investigator (e.g., QTcF interval (Fridericia's formula) >450 msec for males, >470 msec for females; PR interval >200 msec, etc.).
- Subjects with systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg at screening.
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 |
|---|---|---|
| Drug：HS-10510；Drug：HS-10510 Description：Subjects will receive HS-10510 orally as a single and multiple ascending dose. | Drug | Part A-HS-10510 dose 1/placebo, Part A-HS-10510 dose 2/placebo, Part A-HS-10510 dose 4/placebo, Part A-S-10510 dose 3/placebo, Part B-HS-10510 dose 1/placebo, Part B-HS-10510 dose 2/placebo, Part B-HS-10510 dose 3/placebo, Part C-HS-10510/Placebo with rosuvastatin |
| Drug：PlaceboDrug：Placebo Description：Subjects will receive placebo matching the HS-10510 dose orally as a single and multiple ascending dose. | Drug | Part A-HS-10510 dose 1/placebo, Part A-HS-10510 dose 2/placebo, Part A-HS-10510 dose 4/placebo, Part A-S-10510 dose 3/placebo, Part B-HS-10510 dose 1/placebo, Part B-HS-10510 dose 2/placebo, Part B-HS-10510 dose 3/placebo, Part C-HS-10510/Placebo with rosuvastatin |
| Drug： RosuvastatinDrug：Rosuvastatin Description：Subjects will receive rosuvastatin orally. | Drug | Part C-HS-10510/Placebo with rosuvastatin |
Primary outcome
Number of subjects with Adverse Events
Time frame: From Screening until Follow-up Visit (7 days post-dose for all cohorts)
The safety and tolerability of HS-10510 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B and C) will be assessed.
10 secondary outcomes
LDL-C
Time frame: SAD cohorts: Days 1,2,3,4,8 Food Effect SAD cohort: Day 1,2,3,4,8,9,10,11,15 MAD cohorts: Days1,2,3,4,7,11,15,22,26,28,31,35 Rosuvastatin MAD Cohorts: Days1,2,3,4,7,11,15,22,26,28,31,35
Proprotein convertase subtilisin/kexin type 9(PCSK9)
Time frame: SAD cohorts: Days 1,2,3,8 Food Effect SAD cohort: Day 1,2,3,8,9,10,15 MAD cohorts: Days 1,2,3,7,11,15,22,28,31,35 Rosuvastatin MAD Cohorts: Days 1,2,3,7,11,15,22,28,31,35
HS-10510 PK parameter: Maximum observed plasma concentration (Cmax)
Time frame: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Area under plasma concentration-time curve from zero to infinity (AUC0-inf)
Time frame: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUC0-last)
Time frame: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Area under the plasma concentration-curve across the dosing interval (AUC0-tau)
Time frame: MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Time to reach maximum observed concentration (Tmax)
Time frame: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Terminal elimination half-life (t½)
Time frame: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Apparent total body clearance (CL/F)
Time frame: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
HS-10510 PK parameter: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: SAD cohorts: Day 1 to Day 4 Food Effect SAD cohort: Day 1 to Day 4 and Day 8 to Day 11 MAD cohorts: Day 1 to Day 31 Rosuvastatin MAD Cohorts: Day 1 to Day 31
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 3 Jun 2025.
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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 Drug：HS-10510； and Drug： Rosuvastatin 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 22 inclusion and 36 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 3 Jun 2025. 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. 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 Drug Trials (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 Follow-up Visit (7 days post-dose for all cohorts)). 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 3 Jun 2025.