NCT06857253

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 in Healthy Subjects

A Phase I, Randomized, Double-blind and Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 Following Single and Multiple Dose Administration in Healthy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-1301 following single and multiple dose administration in healthy subjects. The study consists of two parts (Part 1 and Part 2) with 82 subjects planned to be enrolled. Possible adjustments to sample size, treatment duration and follow-up time will depend upon emerging data.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	HRS-1301	HRS-1301.
DRUG	HRS-1301 placebo	HRS-1301 placebo.

Timeline

• Start date: 2025-03-18
• Primary completion: 2025-08-11
• Completion: 2025-08-11
• First posted: 2025-03-04
• Last updated: 2025-12-19

Locations

1 site across 1 country: China