A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10510 in Healthy Subjects

NCT07001787 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10510-101
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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). 32 subjects have been planned for Part A and up to 36 subjects for Part B and 20 subjects for Part C.

Conditions

Dyslipidemia

Keywords

Elevated LDL-C；Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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.

  From Screening until Follow-up Visit (7 days post-dose for all cohorts)

Secondary Outcomes (10)

• LDL-C

  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)

  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)

  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)

  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)

  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

Study Arms (8)

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

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

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

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

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

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

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

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

Drug: Drug：HS-10510；; Drug: Drug：Placebo; Drug: Drug： Rosuvastatin

Interventions

Drug：HS-10510； DRUG

Drug：HS-10510 Description：Subjects will receive HS-10510 orally as a single and multiple ascending dose.

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：Placebo DRUG

Drug：Placebo Description：Subjects will receive placebo matching the HS-10510 dose orally as a single and multiple ascending dose.

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： Rosuvastatin DRUG

Drug：Rosuvastatin Description：Subjects will receive rosuvastatin orally.

Part C-HS-10510/Placebo with rosuvastatin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Haiyan Li Director of Institution for Drug Trials

CONTACT

010-68966677-8508; haiyanli1027@hotmail.com

Fangfang Wang NA

CONTACT

010-68966677-8508; doctorfancy@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: June 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05