NCT06441227

Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects

Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Food Effects of Single and Multiple Oral HRS-5346 Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346.

Conditions

• Lipoprotein Disorder Disease

Interventions

Type	Name	Description
DRUG	HRS-5346 tablets	Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses.
DRUG	placebo	Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses.

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-01-09
• Completion: 2025-01-09
• First posted: 2024-06-04
• Last updated: 2025-04-29

Locations

1 site across 1 country: China