NCT07001787

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Drug：HS-10510；	Drug：HS-10510 Description：Subjects will receive HS-10510 orally as a single and multiple ascending dose.
DRUG	Drug：Placebo	Drug：Placebo Description：Subjects will receive placebo matching the HS-10510 dose orally as a single and multiple ascending dose.
DRUG	Drug： Rosuvastatin	Drug：Rosuvastatin Description：Subjects will receive rosuvastatin orally.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2025-06-03
• Last updated: 2025-06-03