NCT06700720

YN001-004 in Patients With Coronary Atherosclerosis in Australia

A Phase Ⅱa Clinical Study to Evaluate the Efficacy and Safety of YN001 in Patients With Coronary Atherosclerosis in Australia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Beijing Inno Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of intravenously administered YN001 in patients with coronary atherosclerosis in Australia. This study will be conducted in eligible participants with a diagnosis of coronary atherosclerosis, and at least 1 coronary artery is blocked determined by coronary computed tomography angiography (CCTA)

Detailed description

This is a multicenter, randomized, open label, parallel-group, proof of concept study. It is designed to determine if the study drug, called YN001, administered in addition to evolocumab can effectively reduce the total amount of plaque formed in the coronary artery as measured by CCTA from baseline to week 13. A total of 24 patients with coronary atherosclerosis are expected to be enrolled and will be randomly assigned in a 1:1 ratio to 1 of 2 YN001 treatment arms (12 patients per arm) with 2 different dose levels for 12 weeks. The study will be comprised of a maximum 41-day screening period (Day -42-Day -2), a baseline period (Day-1), a treatment and observation period (W1D1- W13D7), and a safety follow-up period (14 days post last dose).

Conditions

• Coronary Artery Disease
• Coronary Atherosclerotic Disease

Interventions

Type	Name	Description
DRUG	Dose 1 YN001	Dose 1 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.
DRUG	Dose 2 YN001	Dose 2 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.
DRUG	Evolocumab	Evolocumab 140 mg will be administered subcutaneously every 2 weeks.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-11-22
• Last updated: 2026-02-17

Locations

7 sites across 1 country: Australia