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

NCT06621576 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HM2002 injection

Eligible subjects under general anesthesia will undergo CABG surgery. After completing the distal anastomosis, 5mg of HM2002 injection solution drawn into a 1 ml syringe will be administered via multi-point injection using an OT needle or insulin needle (preferably a 30G needle). The injections will be spaced approximately 1 cm apart, with no more than 30 injection points, into the myocardium at the edge of the MI area (with obvious infarcts) or the area of the diseased coronary artery branches (without obvious infarcts) through the epicardium.

Sponsors & Collaborators

  • Shanghai CirCode Biomed Co.,Ltd

    collaborator INDUSTRY

  • Shanghai Bestudy Medical Technology Co., Ltd

    collaborator UNKNOWN

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Qiang Zhao, MD · Ruijin Hospital

  • Yunpeng Zhu, MD · Ruijin Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-18
Primary Completion
2025-05-26
Completion
2025-05-26

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06621576 on ClinicalTrials.gov