Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621576
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Safety and Tolerability of Epicardial Circular RNA-HM2002 Injection in CABG for Ischemic Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploratory Study on the Safety and Tolerability of Novel Circular RNA-HM2002 Injected Epicardially During Coronary Artery Bypass Grafting in Ischemic Heart Failure Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This study is a prospective single-center single-dose open-label investigator-initiated exploratory clinical trial IIT study designed to evaluate the safety tolerability and potential clinical efficacy of the exploratory dose HM2002 injection administered via single-dose multiple-point injections through the epicardium for the treatment of ischemic heart failure The study plans to enroll three patients aged between 18 and 80 years who are scheduled to undergo elective coronary artery bypass grafting CABG surgery and have ischemic heart failure Eligible patients will become study subjects after providing full written informed consent and successfully passing the inclusion and exclusion criteria screening The exploratory dose for this trial is 5 mg HM2002 injection The three subjects will be dosed following the sentinel dosing principle Specifically after the first subject completes dosing there will be a minimum interval of 14 days 2 weeks to confirm safety and tolerability before enrolling the remaining two subjects If any serious adverse event SAE or dose-limiting toxicity DLT occurs in the first subject a Safety Review Committee SRC meeting will be convened to review all collected safety data The committee will then determine whether to proceed with the enrollment of subsequent subjects or terminate the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None