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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
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-12-16
Primary completion: 2025-09-11
Study completion finish: 2025-09-11
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06700720
Intervention or treatment
DRUG: Dose 1 YN001
DRUG: Dose 2 YN001
DRUG: Evolocumab
Conditions
- • Coronary Artery Disease
- • Coronary Atherosclerotic Disease
Find a site
Closest Location:
Canberra Hospital
Research sites nearby
Select from list below to view details:
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Core Research Group Pty Ltd
Milton, Queesland, Australia
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
|
EXPERIMENTAL: Dose 2 treatment arm
| DRUG: Dose 2 YN001
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 |
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