YN001-004 in Patients With Coronary Atherosclerosis in Australia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Inno Medicine Co., Ltd.
About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Dose 1 YN001
- Dose 2 YN001
- Evolocumab
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov