A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of SGC001 Injection in Chinese Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction and Planned for Primary Percutaneous Coronary Intervention (pPCI)

A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction (NCT07306182) is a Phase 2 interventional studying Anterior Myocardial Infarction, sponsored by Beijing Sungen Biomedical Technology Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The research study is being done to see if SGC001 can be used to treat people scheduled to undergo percutaneous coronary intervention for Anterior ST-segment Elevation Myocardial Infarction. SGC001 might reduce the infarct size and inhibited inflammation, thereby preventing the incidence of major adverse cardiovascular events(MACE) events. Participants will either get SGC001 (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting SGC001 or placebo is the same. The participant was administered intravenously once. SGC001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Anterior Myocardial Infarction and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 210 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Anterior Myocardial Infarction subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 18-79 years of age (including boundary values), male or female; 2. Anterior wall STEMI: (a) history of persistent chest pain/precordial discomfort (\>30 minutes); (b) upon admission, the ECG must meet the Anterior wall STEMI requirements: 3. Planned for pPCI treatment; 4. Assessed as being able to complete dosing within 6 hours of the onset of persistent chest pain/precordial discomfort symptoms; 5. The participant or their legal guardian fully understands the objectives, nature, methods, and potential adverse reactions of the study, voluntarily agrees to participate, and has signed the willing to sign a consent form form (ICF). Who Should NOT Join This Trial: 1. History of the following cardiac conditions: 1. History of myocardial infarction, coronary revascularization (including percutaneous coronary intervention \[PCI\] and coronary artery bypass grafting \[CABG\], etc.); 2. History of cardiopulmonary resuscitation; 3. History of stroke; 4. Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm (including new-onset ventricular aneurysm); 2. Patients who have received thrombolysis; 3. Patients with a life expectancy of less than 1 year; 4. Febrile infection requiring systemic treatment within 2 weeks prior to screening; 5. Left bundle branch block (QRS duration ≥0.12 seconds. Broad R waves in leads V5 and V6, with a notch or slurring at the top, and no preceding q wave. Broad S waves or rS patterns in leads V1 and V2. T waves in leads V5 and V6 are opposite in direction to the main QRS wave); 6. Cardiogenic shock or hemodynamic instability; 7. Concomitant severe arrhythmia (including high-degree atrioventricular block, sick sinus syndrome, sustained ventricular tachycardia, etc.) or implanted cardiac pacemaker; 8. Definitive diagnosis of acute cardiac failure (Killip classification ≥ III; for details on Killip classification, see Appendix); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. 18-79 years of age (including boundary values), male or female; 2. Anterior wall STEMI: (a) history of persistent chest pain/precordial discomfort (\>30 minutes); (b) upon admission, the ECG must meet the Anterior wall STEMI requirements: 3. Planned for pPCI treatment; 4. Assessed as being able to complete dosing within 6 hours of the onset of persistent chest pain/precordial discomfort symptoms; 5. The participant or their legal guardian fully understands the objectives, nature, methods, and potential adverse reactions of the study, voluntarily agrees to participate, and has signed the informed consent form (ICF). Exclusion Criteria: 1. History of the following cardiac conditions: 1. History of myocardial infarction, coronary revascularization (including percutaneous coronary intervention \[PCI\] and coronary artery bypass grafting \[CABG\], etc.); 2. History of cardiopulmonary resuscitation; 3. History of stroke; 4. Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm (including new-onset ventricular aneurysm); 2. Patients who have received thrombolysis; 3. Patients with a life expectancy of less than 1 year; 4. Febrile infection requiring systemic treatment within 2 weeks prior to screening; 5. Left bundle branch block (QRS duration ≥0.12 seconds. Broad R waves in leads V5 and V6, with a notch or slurring at the top, and no preceding q wave. Broad S waves or rS patterns in leads V1 and V2. T waves in leads V5 and V6 are opposite in direction to the main QRS wave); 6. Cardiogenic shock or hemodynamic instability; 7. Concomitant severe arrhythmia (including high-degree atrioventricular block, sick sinus syndrome, sustained ventricular tachycardia, etc.) or implanted cardiac pacemaker; 8. Definitive diagnosis of acute cardiac failure (Killip classification ≥ III; for details on Killip classification, see Appendix); 9. Unable to undergo cardiac magnetic resonance (CMR) imaging according to the study protocol, or known allergy to any radiocontrast agent; 10. Participation in other drug clinical trials and use of other investigational drugs within 3 months before receiving the study drug; 11. Concomitant history of the following serious diseases: 1. Severe hepatic or renal insufficiency (e.g., requiring dialysis); 2. Malignant tumor or history of malignant tumor; 3. Severe autoimmune disease requiring therapeutic intervention; 12. Men and women of childbearing potential (WOCBP) who are fertile and have plans to conceive during the study period, as well as pregnant or lactating women;

Treatments Being Tested

DRUG

SGC001

The single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes.

DRUG

Placebo

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Linfen Central Hospital

Linfen, Shanxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07306182), the sponsor (Beijing Sungen Biomedical Technology Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07306182 clinical trial studying?

The research study is being done to see if SGC001 can be used to treat people scheduled to undergo percutaneous coronary intervention for Anterior ST-segment Elevation Myocardial Infarction. SGC001 might reduce the infarct size and inhibited inflammation, thereby preventing the incidence of major adverse cardiovascular events(MACE) events. Participants will either get SGC001 (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting SGC001 or placebo is the same. The participant was administered … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07306182?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07306182?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07306182. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07306182. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.