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)

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Myocardial Infarction
• Intervention / Treatment: Drug: SGC001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Zhang, Bachelor; Phone Number: 010-50973600 010-50973600; Email: wei.zhang@sungenbiomed.com.cn
• Study Contact Backup: Name: Mei Tong, Doctor; Phone Number: 010-50973600 010-50973600; Email: mei.tong@sungenbiomed.com.cn

Study Locations

• China
  • Shanxi
    • Linfen, Shanxi, China, 041099
      • Recruiting
      • Linfen Central Hospital
      • Contact: Wei Zhang, Bachelor; Phone Number: 010-50973600; Email: wei.zhang@sungenbiomed.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SGC001; Enrolled anterior STEMI patients will receive standard clinical treatment and a single dose of SGC001 on Day 1 (D1) according to their randomized dosing group. The study drug should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection will be administered over 10 minutes.	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.
Placebo Comparator: Placebo; Enrolled anterior STEMI patients will receive standard clinical treatment and a single dose of placebo on Day 1 (D1) according to their randomized dosing group. The study drug should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection will be administered over 10 minutes.	Drug: Placebo; 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. Other Name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of myocardial infarction size	Percentage of myocardial infarction size	Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of myocardial infarction size	Percentage of myocardial infarction size	Day 30, Day 90
Percentage of microvascular obstruction area (MVO)	Percentage of microvascular obstruction area (MVO)	Day 4, Day 30, Day 90
Myocardial salvage index	Myocardial salvage index	Day 4
Left ventricular ejection fraction (LVEF)	Left ventricular ejection fraction (LVEF)	Day 4, Day 90
Left ventricular end-systolic volume index (LVESVI)	Left ventricular end-systolic volume index (LVESVI)	Day 4, Day 90
Left ventricular end-diastolic volume index (LVEDVI)	Left ventricular end-diastolic volume index (LVEDVI)	Day 4, Day 90
Composite incidence of cardiovascular death	Composite incidence of cardiovascular death	Day 90
Incidence of cardiovascular death	Incidence of cardiovascular death	Day 90
Incidence of cardiac failure events	Incidence of cardiac failure events	Day 90
safety endpoints	Adverse events (AEs)/serious adverse events (SAEs)：physical examinations/vital signs/ECGs/laboratory tests	within 90 days

Collaborators and Investigators

• Sponsor: Beijing Sungen Biomedical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; Anterior Wall Myocardial Infarction
• Other Study ID Numbers: SG-SGC001-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) will be shared when necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No