RecruitingAtherosclerosisCoronary Artery Disease

A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis

Eligible age

18–80 yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.

Sponsor: Beijing Inno Medicine Co., Ltd.

You may qualify if…

✓ 1. Fully understands the purposes, features, and methods of the study and the possible adverse reactions, and is voluntarily willing to participate in the study, and signs the informed consent form (ICF) before performing any study-specific assessment.
✓ 2. Male or female participants between 18 and 80 years (inclusive, at the time of signing the ICF).
✓ 3. Participants must satisfy either of the following criteria:
✓ 1\) Have clinically evident atherosclerotic CV disease (ASCVD) 2) Meet at least two of the following criteria at screening/baseline, as evidenced by:
✓ 1. A history of Type 2 diabetes requiring treatment with medication,
✓ 2. Aged \> 55 years (women) or \> 50 years (men),
✓ 3. 2 or more of the following atherosclerosis risk factors:
✓ Current cigarette smoker

You may not qualify if…

✕ 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, or any planned vaccination during the study treatment period
✕ 4. Contraindication for CCTA
✕ 5. 3 major epicardial coronary arteries with ≥ 70% or left main ≥50% stenosis.
✕ 6. Acute MI that occurred within 4 weeks prior to randomization.
✕ 7. PCI performed within 2 weeks prior to randomization or PCI is required or planned during study treatment based on clinical indication for revascularization.
✕ 8. Clinically evident stroke or transient ischemic attack (TIA) within 6 months prior to randomization.