Actively Recruiting
YN001-004 in Patients With Coronary Atherosclerosis in Australia
Led by Beijing Inno Medicine Co., Ltd. · Updated on 2026-02-17
24
Participants Needed
7
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
YN001-004 in Patients With Coronary Atherosclerosis in Australia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study purpose, methods, and sign informed consent before any assessments
- Male or female patients aged 18 to 75 years in Australia
- Diagnosed with coronary atherosclerosis with at least one vessel blocked as shown by coronary CTA
- Female patients must not be pregnant or breastfeeding and must use effective contraception from screening until 3 months after last dose; male patients must agree to avoid sperm donation during this time
- Willing and able to follow the study protocol requirements to the best of their and investigators' knowledge
You will not qualify if you...
- Received other investigational drugs within 30 days or 5 half-lives before randomization
- Previously treated with YN001
- Received any vaccination within 4 weeks before randomization
- Contraindicated for coronary CTA (e.g., history of severe allergic reactions to contrast)
- Multi-vessel severe coronary disease
- Recent acute STEMI within 2 weeks before randomization
- Uncontrolled symptomatic arrhythmia in the last 3 months
- Prior or planned heart surgeries such as CABG, heart transplant, SAVR/TAVR
- PCI done within 4 weeks before randomization or planned during study
- NYHA class III or IV heart failure or last known LVEF below 40%
- Stroke within 6 months before randomization (except TIA)
- History or risk of muscle disease such as myopathy or rhabdomyolysis
- Known inflammatory bowel disease or recent gastrointestinal bleeding
- Major diseases not recovered within 2 weeks before randomization or planned major surgery
- History of cancer unless disease-free for over 5 years or only basal/squamous skin cancer
- Any autoimmune disease
- Allergies to multiple foods or drugs or sensitivity to study drug components
- Life expectancy under 1 year
- Systolic blood pressure 150 mmHg or higher despite medication
- Known familial hypercholesterolemia
- Triglycerides 400 mg/dl or higher at screening
- Active liver disease or liver function tests over twice the normal limit
- Renal insufficiency
- Untreated or poorly treated hypothyroidism
- Poorly controlled type 2 diabetes (HbA1c over 9%)
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Current smoker averaging 5 or more cigarettes per day over the past year
- Other diseases or conditions making participation unsuitable per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Actively Recruiting
2
Albury Wodonga Private Hospital
Albury, New South Wales, Australia, 1125
Actively Recruiting
3
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
4
Core Research Group Pty Ltd
Milton, Queesland, Australia
Withdrawn
5
Altona Clinical Research
Melbourne, Victoria, Australia, 3025
Actively Recruiting
6
Peninsula Heart Centre
Melbourne, Victoria, Australia, 3199
Actively Recruiting
7
John Flynn Private Hospital
Tugun, Australia
Not Yet Recruiting
Research Team
J
Jean Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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