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)

This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of SGC001 injection administered in addition to standard clinical care in Chinese patients with acute anterior ST-segment elevation myocardial infarction (STEMI) who are planned for primary percutaneous coronary intervention (pPCI).

Study Overview

• Status: Recruiting
• Conditions: Acute Anterior ST-Segment Elevation Myocardial Infarction
• Intervention / Treatment: Drug: SGC001 injection; Drug: SGC001 injection; Drug: Placebo

Detailed Description

The study drug will be administered intravenously within 6 hours of the onset of acute myocardial infarction symptoms, on top of standard of care.

The primary efficacy endpoint is the percentage of myocardial infarction size on Day 4 post-dosing, assessed by cardiac magnetic resonance (CMR) imaging.

Secondary endpoints include myocardial infarction size at Day90, microvascular obstruction area and left ventricular function parameters at Day4 and Day90, myocardial salvage index at Day4, biomarkers (hs-TnI, hs-CRP, CK-MBmass, NT-proBNP), and composite incidence of cardiovascular death or heart failure events within 90 days. Safety assessments include adverse events, serious adverse events, physical examinations, vital signs, ECGs, and laboratory tests. Participants will undergo follow-up visits at Days 30 and 90, with a telephone follow-up at Day 180 to record survival status and heart failure events.

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

Contacts and Locations

• Study Contact: Name: Wei Gao, Doctor; Phone Number: 010-50973600 010-50973600; Email: wei.gao@sungenbiomed.com.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200120
      • Recruiting
      • Shanghai East Hospital

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 following requirements: i.For male participants >40 years old, ST-segment elevation ≥2 mm in leads V2 and V3; ii.For male participants ≤40 years old, ST-segment elevation ≥2.5 mm in leads V2 and V3; iii.For female participants, ST-segment elevation ≥1.5 mm in leads V2 and V3; If clinical symptoms of (a) are atypical, then (c) a positive point-of-care troponin test is required.

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 within 6 months;
   4. Presence of severe cardiac structural abnormalities such as aortic dissection, and 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. Concomitant left bundle branch block;
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 heart 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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Placebo	Drug: Placebo; Dosage: 0mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)
Experimental: Test Group 1; SGC001 injection 600 mg single dose	Drug: SGC001 injection; Dosage: 600mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing); Drug: SGC001 injection; Dosage: 900mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)
Experimental: Test Group 2; SGC001 injection 900 mg single dose	Drug: SGC001 injection; Dosage: 600mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing); Drug: SGC001 injection; Dosage: 900mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass)	Day 4 post-dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of myocardial infarction size		Day 90 post-dosing
Percentage of microvascular obstruction area (MVO)		Day 4 and Day 90 post-dosing
Myocardial salvage index		Day 4 post-dosing
Left ventricular ejection fraction (LVEF), left ventricular end-systolic volume index (LVESVI), and left ventricular end-diastolic volume index (LVEDVI)		Day 4 and Day 90 post-dosing
High-sensitivity troponin I (hs-TnI), high-sensitivity C-reactive protein (hs-CRP), creatine kinase-MB mass (CK-MBmass)		baseline (pre-dose), and at 1 hour, 8 hours, Day 2, Day 5, and Day 30 post-dosing
N-terminal pro-brain natriuretic peptide (NT-proBNP)		baseline (pre-dose), and at 1 hour, 8 hours, Day 2, Day 5, Day 30, Day90 post-dosing
Composite incidence of cardiovascular death or heart failure events		Within 90 days post-dosing
Incidence of cardiovascular death		Within 90 days post-dosing
Incidence of heart failure events		Within 90 days post-dosing
Safety endpoints	Adverse events (AEs)/serious adverse events (SAEs)/physical examinations/vital signs/ECGs/laboratory tests	Within 90 days post-dosing

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): April 1, 2027
• Study Completion (Estimated): October 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): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Acute Anterior ST-Segment Elevation Myocardial Infarction; ST-Segment Elevation Myocardial Infarction(STEMI)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation 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