Overview

First-in-Human Pilot Study of Epicardial Circular RNA-HM2002 Injection in CABG for Ischemic Heart Failure

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2025-09-01

Target enrollment:

Participant gender:

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.

Phase:

EARLY_PHASE1

Details

Lead Sponsor:

Ruijin Hospital

Collaborators:

Shanghai Bestudy Medical Technology Co., Ltd
Shanghai CirCode Biomed Co.,Ltd