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

NCT07306182 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SG-SGC001-201
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Anterior ST-Segment Elevation Myocardial Infarction

Keywords

Acute Anterior ST-Segment Elevation Myocardial Infarction; ST-Segment Elevation Myocardial Infarction(STEMI)

Outcome Measures

Primary Outcomes (1)

• Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass)

  Day 4 post-dosing

Secondary Outcomes (10)

• 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

Study Arms (3)

Test Group 1

EXPERIMENTAL

SGC001 injection 600 mg single dose

Drug: SGC001 injection

Test Group 2

EXPERIMENTAL

SGC001 injection 900 mg single dose

Drug: SGC001 injection

Control Group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

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)

Control Group

SGC001 injection DRUG

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)

Test Group 1

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age (including boundary values), male or female;
• 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.
• Planned for pPCI treatment;
• Assessed as being able to complete dosing within 6 hours of the onset of persistent chest pain/precordial discomfort symptoms;
• 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).

You may not qualify if:

• History of the following cardiac conditions:
• History of myocardial infarction, coronary revascularization (including percutaneous coronary intervention \[PCI\] and coronary artery bypass grafting \[CABG\], etc.);
• History of cardiopulmonary resuscitation;
• History of stroke within 6 months;
• Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm;
• Patients who have received thrombolysis;
• Patients with a life expectancy of less than 1 year;
• Febrile infection requiring systemic treatment within 2 weeks prior to screening;
• Concomitant left bundle branch block;
• Cardiogenic shock or hemodynamic instability;
• Concomitant severe arrhythmia (including high-degree atrioventricular block, sick sinus syndrome, sustained ventricular tachycardia, etc.) or implanted cardiac pacemaker;
• Definitive diagnosis of acute heart failure (Killip classification ≥ III; for details on Killip classification, see Appendix);
• Unable to undergo cardiac magnetic resonance (CMR) imaging according to the study protocol, or known allergy to any radiocontrast agent;

Sponsors & Collaborators

• Beijing Sungen Biomedical Technology Co., Ltd: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Wei Gao, Doctor

CONTACT

010-50973600; wei.gao@sungenbiomed.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: December 29, 2025
• Study Start: March 9, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)