First-in-Human Pilot Study of Epicardial Circular RNA-HM2002 Injection in CABG for Ischemic Heart… (NCT06621576) | Clinical Trial Compass
CompletedEarly Phase 1
First-in-Human Pilot Study of Epicardial Circular RNA-HM2002 Injection in CABG for Ischemic Heart Failure
China3 participantsStarted 2024-09-18
Plain-language summary
This exploratory, single-center, open-label clinical trial assesses the safety, tolerability, and potential efficacy of a single 5 mg dose of HM2002 injection administered via multiple-point epicardial injections for treating ischemic heart failure. Three patients aged 18-80 undergoing elective coronary artery bypass grafting (CABG) surgery will participate. Using a sentinel dosing approach, the first subject will receive HM2002, followed by a 14-day safety observation before dosing the remaining participants. If any serious adverse events or dose-limiting toxicities occur in the first subject, a Safety Review Committee will evaluate the safety data to determine whether to continue or terminate the trial.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. be ≥18 and ≤80 years of age at the time of signing the informative and be of either sex;
✓. have ischemic heart failure (IHF) with left ventricular ejection fraction (LVEF) ≤50% by echocardiography (ECHO), New York Heart Association (NYHA) cardiac function class 3-4, and be proposed to undergo elective coronary artery bypass grafting (CABG);
✓. voluntarily sign the informed consent form and fully understand the content, process and possible adverse reactions of the trial. Be able to complete the study according to the requirements of the trial protocol and have good compliance;
Exclusion criteria
✕. subjects with the following concomitant symptoms or diseases:
✕. ECHO-confirmed LVEF ≤ 20%;
✕. History of malignant arrhythmias (including multiple ventricular pre-systole, premature ventricular dystocia, tricyclic rhythm, or ventricular tachycardia) manifesting symptomatically or requiring treatment (CTCAE grade 3);
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Clinically Meaningful Changes from Baseline in Clinical Laboratory Tests, Vital Signs, and Electrocardiogram Parameters