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A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 in Healthy Subjects and Subjects With Mildly Elevated LDL-C Levels
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
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).
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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2026-09-30
Completion Date
2027-12-31
Last Updated
2026-08-20
Healthy Volunteers
Yes
Conditions
Interventions
HS-10582
Drug:HS-10582 Description:Subjects will receive HS-10582 orally as a single and multiple ascending dose.
Placebo
Drug:Placebo Description:Subjects will receive placebo matching the HS-10582 dose orally as a single and multiple ascending dose.