drugset / Trial / NCT06621576
First-in-Human Pilot Study of Epicardial Circular RNA-HM2002 Injection in CABG for Ischemic Heart Failure
Phase 0
Completed
3 enrolled
Ruijin Hospital
Shanghai Bestudy Medical Technology Co., Ltd · collabShanghai CirCode Biomed Co.,Ltd · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-09-18
- Primary completion
- 2025-05-26
- Completion
- 2025-05-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HM2002 | Other / unclassified | 5 mg | Other |