Ischaemic Heart DiseaseEarly Phase 1NCT06621576
First-in-Human Pilot Study of Epicardial Circular RNA-HM2002 Injection in CABG for Ischemic Heart Failure
A Early Phase 1 study testing HM2002 injection in people with Ischaemic Heart Disease and Heart Failure, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischaemic Heart Disease, Heart Failure
- What is being tested?
- HM2002 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2024to 26 May 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following 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;
Who cannot join
- Subjects meeting any of the following criteria will be excluded from this study:
- 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);
- atrial fibrillation (including paroxysmal atrial fibrillation);
- Long QT syndrome;
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- Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2; f. Serum gammaglutamyl (GGT) ≤ 1.5 mL/min/1.73 m2
- Serum alanine aminotransferase (ALT) or aminotransferase (AST) > 3 x upper limit normal (ULN) and total bilirubin (TBIL) > 2 x ULN or more;
- Severe coagulation disorders, bleeding disorders, etc;
- history of active human immunodeficiency virus (HIV), active hepatitis C virus (HCV), or active hepatitis B virus (HBV); active HIV, HCV, and HBV infections are defined as:
- <!-- -->
- HIV antibody positive;
- Anti-HCV antibody and positive for HCV RNA;
- HBsAg positive and HBV DNA ≥1000 cps/ml (or 200 IU/ml); i. current malignancy, or a history of malignancy.
- need for concurrent cardiac or non-cardiac interventional or surgical procedures other than CABG (e.g., valve surgery, ventricular wall tumor surgery, peripheral arterial stenting or surgery)
- patients with prior systemic or cardiac therapy with similar nucleic acid medications
- a known history of drug abuse or drug allergy
- pregnant or lactating women or those who are not using effective contraception;
- other circumstances judged by the investigator to be inappropriate, such as the investigator's judgment that the subject may be exposed to substantial safety risks, or interference with the results of the study, or lack of participation in completing this trial in accordance with the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
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.
Read the 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.
- Conditions
- Ischaemic Heart Disease, Heart Failure
- Being tested
- HM2002 injection
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM2002 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HM2002 Injection group | Experimental | First sentinel enrollment, no DLT events followed by re-enrollment after 2 cases Receives: Drug: HM2002 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Clinically Meaningful Changes from Baseline in Clinical Laboratory Tests, Vital Signs, and Electrocardiogram Parameters
To assess the safety of a single 5 mg dose of HM2002 injection in treating ischemic heart failure by evaluating the incidence of adverse events (AEs) and serious adverse events (SAEs) as categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, along with clinically meaningful changes from baseline in clinical laboratory tests (including complete blood count [CBC], liver function tests [LFTs], renal function tests [RFTs], and coagulation function), vital signs (such as systolic and diastolic blood pressure, heart rate, respiratory rate, and body temperature), and 12-lead electrocardiogram (ECG) parameters (including heart rhythm disturbances, ST segment deviations, T wave abnormalities, and alterations in PR or QT interval).
Measured: 6 months
Secondary outcomes (9)
Myocardial Perfusion Changes
Changes in blood perfusion of the ischemic myocardial injection segments measured by resting cardiac magnetic resonance (CMR) perfusion imaging
Measured: Baseline, 6 months
CMR Assessment of LVEF
Changes in LVEF assessed by CMR
Measured: Baseline, 6 months
NT-proBNP Level Changes
Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels
Measured: Baseline, 1 month, 3 months, and 6 months
Echocardiographic Assessment of Cardiac Function
Changes in Left Ventricular Ejection Fraction (LVEF) assessed by echocardiography
Measured: Baseline, 1 month, 3 months, and 6 months
Perfusion Changes in Ischemic Myocardium
Changes in perfusion of the ischemic myocardial injection segments measured by SPECT
Measured: Baseline, 6 months
Metabolism Changes in Ischemic Myocardium
Changes in metabolism of the ischemic myocardial injection segments measured by PET
Measured: Baseline, 6 months
Angina Score Changes
Changes in angina score measured by the Seattle Angina Questionnaire (SAQ), ranging from 0 to 100 per domain, with higher scores indicating a better outcome.
Measured: Baseline, 1 month, 3 months, and 6 months
Quality of Life Changes
Changes in quality of life (QoL) assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), ranging from 0 to 105, with higher scores indicating a worse outcome.
Measured: Baseline, 1 month, 3 months, and 6 months
NYHA Functional Classification Changes
Changes in New York Heart Association (NYHA) functional classification. The NYHA classification ranges from Class 1 to 4. Higher scores (Class 4) indicate worse functional status, while lower scores (Class 1) indicate better functional capacity.
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start18 Sep 2024
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai CirCode Biomed Co.,Ltd, Shanghai Bestudy Medical Technology Co., Ltd
- Responsible party
- Principal investigator, Qiang Zhao,MD, Ruijin Hospital
- Investigators
- Qiang Zhao, MD, Principal investigator, Ruijin HospitalYunpeng Zhu, MD, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621576
- Sponsor's protocol ID
- HM2002-001
- Status last verified
- May 2026
- First submitted
- 17 Sep 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Pilot Study of Epicardial Circular RNA-HM2002 Injection in CABG for Ischemic Heart Failure
- ClinicalTrials.gov ID
- NCT06621576
- Acronym / sponsor ID
- HM2002-001
- Conditions
- Ischaemic Heart Disease, Heart Failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai CirCode Biomed Co.,Ltd, Shanghai Bestudy Medical Technology Co., Ltd
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM2002 Injection group | Experimental | Drug: HM2002 injectionFirst sentinel enrollment, no DLT events followed by re-enrollment after 2 cases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (19 listed)
- subjects with the following concomitant symptoms or diseases:
- <!-- -->
- need for concurrent cardiac or non-cardiac interventional or surgical procedures other than CABG (e.g., valve surgery, ventricular wall tumor surgery, peripheral arterial stenting or surgery)
- patients with prior systemic or cardiac therapy with similar nucleic acid medications
- a known history of drug abuse or drug allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM2002 injectionEligible 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. | Drug | HM2002 Injection group |
Primary outcome
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Clinically Meaningful Changes from Baseline in Clinical Laboratory Tests, Vital Signs, and Electrocardiogram Parameters
Time frame: 6 months
To assess the safety of a single 5 mg dose of HM2002 injection in treating ischemic heart failure by evaluating the incidence of adverse events (AEs) and serious adverse events (SAEs) as categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, along with clinically meaningful changes from baseline in clinical laboratory tests (including complete blood count [CBC], liver function tests [LFTs], renal function tests [RFTs], and coagulation function), vital signs (such as systolic and diastolic blood pressure, heart rate, respiratory rate, and body temperature), and 12-lead electrocardiogram (ECG) parameters (including heart rhythm disturbances, ST segment deviations, T wave abnormalities, and alterations in PR or QT interval).
9 secondary outcomes
Myocardial Perfusion Changes
Time frame: Baseline, 6 months
CMR Assessment of LVEF
Time frame: Baseline, 6 months
NT-proBNP Level Changes
Time frame: Baseline, 1 month, 3 months, and 6 months
Echocardiographic Assessment of Cardiac Function
Time frame: Baseline, 1 month, 3 months, and 6 months
Perfusion Changes in Ischemic Myocardium
Time frame: Baseline, 6 months
Metabolism Changes in Ischemic Myocardium
Time frame: Baseline, 6 months
Angina Score Changes
Time frame: Baseline, 1 month, 3 months, and 6 months
Quality of Life Changes
Time frame: Baseline, 1 month, 3 months, and 6 months
NYHA Functional Classification Changes
Time frame: Baseline, 1 month, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Zhao, MD principal investigator
Ruijin Hospital
Yunpeng Zhu, MD study director
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HM2002 injection in people with Ischaemic Heart Disease and Heart Failure, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Clinically Meaningful Changes from Baseline in Clinical Laboratory Tests, Vital Signs, and Electrocardiogram Parameters (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.