YN001-004 in Patients With Coronary Atherosclerosis in Australia

Sponsor
Beijing Inno Medicine Co., Ltd.
Study ID
NCT06700720
Phase
PHASE2
Status
Recruiting
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Conditions

  • Coronary Artery Disease
  • Coronary Atherosclerotic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose 1 treatment arm
    Dose 1 YN001 will be administrated intravenously weekly.
  • Experimental: Dose 2 treatment arm
    Dose 2 YN001 will be administrated intravenously weekly.

Primary Outcome Measure

Changes in coronary plaque characteristics (volume and composition) [ Time Frame: From baseline to Week 13 ]

Central Contacts

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