YN001-004 in Patients With Coronary Atherosclerosis in Australia

Beijing Inno Medicine

Status and phase: Enrolling; Phase 2

Conditions: Coronary Artery Disease; Coronary Atherosclerotic Disease

Treatments: Drug: Evolocumab; Drug: Dose 2 YN001; Drug: Dose 1 YN001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06700720

YN001-004

Details and patient eligibility

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)

Full 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 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).

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.
2. Male or female Australia patients between 18 and 75 years.
3. Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).
4. 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.
5. Willing and able to comply with the requirements of protocol to the best of the patient's and investigator's knowledge.

Exclusion criteria

1. Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.
2. Previously received YN001.
3. Any type of vaccination within 4 weeks prior to randomization.
4. Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).
5. Severe coronary calcification.
6. Multi-vessel severe disease.
7. Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.
8. 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.
9. Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study.
10. PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.
11. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) <40%.
12. Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
13. Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.
14. 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).
15. Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.
16. 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.
17. Presence of renal insufficiency.
18. Poorly controlled (defined by HbA1c > 9%) type 2 diabetes mellitus.
19. 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).
20. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

12 participants in 2 patient groups

Dose 1 treatment arm

Experimental group

Description:

Dose 1 YN001 will be administrated intravenously twice in a week.

Treatment:

Drug: Dose 1 YN001

Drug: Evolocumab

Dose 2 treatment arm

Experimental group

Description:

Dose 2 YN001 will be administrated intravenously weekly.

Treatment:

Drug: Dose 2 YN001

Drug: Evolocumab