YN001-004 in Patients With Coronary Atherosclerosis in Australia
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).
Study details:
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 12 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 (6 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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.
- Male or female Australia patients between 18 and 75 years.
- Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).
- Female patients must be non-pregnant and non-lactating, and females of childbearing potential (including a female partner of a male patient) must agree to use 1 effective contraception method from the screening period to 3 months after receiving their last dose of the study drug. In addition, male patients must be willing to refrain from sperm donation during this time.
- Willing and able to comply with the requirements of protocol to the best of the patient's and investigator's knowledge.
Exclusion criteria
- Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.
- Previously received YN001.
- Any type of vaccination within 4 weeks prior to randomization.
- Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).
- Severe coronary calcification.
- Multi-vessel severe disease.
- Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.
- Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate and paroxysmal supraventricular tachycardia.
- Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study.
- PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.
- New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) <40%.
- Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
- Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.
- Presenting with history of malignancy (except in patients who have been disease-free >5 years; or whose only malignancy has been basal or squamous cell skin carcinoma).
- Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.
- Active liver disease or hepatic dysfunction defined by any of ALT, AST, or total bilirubin > 2 times upper limit of normal (ULN) at final screening.
- Presence of renal insufficiency.
- Poorly controlled (defined by HbA1c > 9%) type 2 diabetes mellitus.
- A positive hepatitis B surface antigen (HBsAg), or positive antibody against hepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positive treponema pallidum antibody (TP-Ab).
- Presence of any other diseases or conditions (apart from those outlined above) that, in the opinion of the investigator, would make it unsuitable for the patient to participate in this study.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT06700720
Intervention or treatment
DRUG: Dose 1 YN001
DRUG: Dose 2 YN001
DRUG: Evolocumab
Conditions
- Coronary Artery Disease
- Coronary Atherosclerotic Disease
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Research sites nearby
Closest Location:
Canberra Hospital
Select from list below to view details:
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Albury Wodonga Private Hospital
Albury, New South Wales, Australia
Core Research Group Pty Ltd
Milton, Queesland, Australia
Altona Clinical Research
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Beijing Inno Medicine Co., Ltd.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dose 1 treatment arm
| Drug: Dose 1 YN001, Drug: Evolocumab |
EXPERIMENTAL: Dose 2 treatment arm
| Drug: Dose 2 YN001, Drug: Evolocumab |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Changes in coronary plaque characteristics (volume and composition) | Evaluating YN001 on top of evolocumab therapy in changing coronary plaque volume assessed by coronary computed tomography angiography (CCTA). | From baseline to Week 13 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean of mean carotid IMT | Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound. | From baseline to Week 13 |
| Change in mean of mean carotid IMT | Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound. | From baseline to Week 5 |
| Change in mean of mean carotid IMT | Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound. | From baseline to Week 9 |
| Change in mean peri-coronary Fat attenuation index (FAI) | Evaluating YN001 on top of evolocumab therapy in changing inflammation using the peri-coronary FAI value measured by quantitative CTA analysis. | From baseline to Week 13 |
| The safety profile of YN001 | Incidence of Adverse events (AEs)/Serious adverse events (SAEs) | From baseline to Week 15 |
| Plasma concentration of total and free drug | Plasma concentration of total and free drug at pre-dose (0 h) and at the end of infusion | From Week 1 to Week 13 |
| Population pharmacokinetics (PK) | Plasma PK parameter (AUC) and patient covariates of interest will be evaluated graphically and in the population PK model. | From Week 1 to Week 13 |
References
Clinical Trials Gov: YN001-004 in Patients With Coronary Atherosclerosis in AustraliaOther trials to consider
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