NCT05531097

Ascending Single-Dose and Multiple-Dose Study to Evaluate HSK31679 in Healthy Subjects and Subjects With Elevated LDL-C

A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses and Multiple Dose of HSK31679 in Healthy Volunteers and Subjects With Elevated LDL-C

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, single-dose and multiple dose escalation clinical trial for HSK31679 conducted in chinese healthy volunteers and LDL-C elevated subjects. The safety, tolerability, food-impact,pharmacokinetics and pharmacodynamics of HSK31679 tablet in healthy volunteers and LDL-C elevated volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design

Conditions

• Healthy
• Elevated LDL-C

Interventions

Type	Name	Description
DRUG	HSK31679	Single or multiple oral doses of HSK31679
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2022-02-22
• Primary completion: 2022-09-21
• Completion: 2022-12-08
• First posted: 2022-09-07
• Last updated: 2024-01-03

Locations

2 sites across 1 country: China