A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 in Healthy Subjects and Subjects With Mildly Elevated LDL-C Levels
NCT07777003 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2026-08-20
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).
Conditions
Interventions
- DRUG
-
HS-10582
Drug:HS-10582 Description:Subjects will receive HS-10582 orally as a single and multiple ascending dose.
- DRUG
-
Drug:Placebo Description:Subjects will receive placebo matching the HS-10582 dose orally as a single and multiple ascending dose.
Sponsors & Collaborators
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-05-30
- Completion
- 2027-12-31
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