Acute Anterior ST-Segment Elevation Myocardial InfarctionPhase 2NCT07306182
A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction
A Phase 2 study testing SGC001 injection in people with Acute Anterior ST-Segment Elevation Myocardial Infarction, run by Beijing Sungen Biomedical Technology Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Anterior ST-Segment Elevation Myocardial Infarction
- What is being tested?
- SGC001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
About this study
Official title: 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).
Read the 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.
- Being tested
- SGC001 injection, Placebo
- Keywords
- Acute Anterior ST-Segment Elevation Myocardial Infarction, ST-Segment Elevation Myocardial Infarction(STEMI)
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGC001 injectionDrug
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)
SGC001 injectionDrug
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)
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Test Group 1 | Experimental | SGC001 injection 600 mg single dose Receives: Drug: SGC001 injection |
| Test Group 2 | Experimental | SGC001 injection 900 mg single dose Receives: Drug: SGC001 injection |
| Control Group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass)
Measured: Day 4 post-dosing
Secondary outcomes (10)
Percentage of myocardial infarction size
Measured: Day 90 post-dosing
Percentage of microvascular obstruction area (MVO)
Measured: Day 4 and Day 90 post-dosing
Myocardial salvage index
Measured: Day 4 post-dosing
Left ventricular ejection fraction (LVEF), left ventricular end-systolic volume index (LVESVI), and left ventricular end-diastolic volume index (LVEDVI)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Within 90 days post-dosing
Incidence of cardiovascular death
Measured: Within 90 days post-dosing
Incidence of heart failure events
Measured: Within 90 days post-dosing
Safety endpoints
Adverse events (AEs)/serious adverse events (SAEs)/physical examinations/vital signs/ECGs/laboratory tests
Measured: Within 90 days post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start9 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Anterior ST-Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306182
- Sponsor's protocol ID
- SG-SGC001-201
- Status last verified
- Jul 2026
- First submitted
- 24 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will be shared when necessary
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07306182
- Acronym / sponsor ID
- SG-SGC001-201
- Keywords
- Acute Anterior ST-Segment Elevation Myocardial Infarction, ST-Segment Elevation Myocardial Infarction(STEMI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Dec 2025 (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 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Group 1 | Experimental | Drug: SGC001 injectionSGC001 injection 600 mg single dose |
| Test Group 2 | Experimental | Drug: SGC001 injectionSGC001 injection 900 mg single dose |
| Control Group | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- History of the following cardiac conditions:
- 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;
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 |
|---|---|---|
| SGC001 injectionDosage: 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 | Test Group 1 |
| SGC001 injectionDosage: 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) | Drug | Test Group 2 |
| PlaceboDosage: 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) | Drug | Control Group |
Primary outcome
Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass)
Time frame: Day 4 post-dosing
10 secondary outcomes
Percentage of myocardial infarction size
Time frame: Day 90 post-dosing
Percentage of microvascular obstruction area (MVO)
Time frame: Day 4 and Day 90 post-dosing
Myocardial salvage index
Time frame: Day 4 post-dosing
Left ventricular ejection fraction (LVEF), left ventricular end-systolic volume index (LVESVI), and left ventricular end-diastolic volume index (LVEDVI)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Within 90 days post-dosing
Incidence of cardiovascular death
Time frame: Within 90 days post-dosing
Incidence of heart failure events
Time frame: Within 90 days post-dosing
Safety endpoints
Time frame: Within 90 days post-dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will be shared when necessary
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGC001 injection in people with Acute Anterior ST-Segment Elevation Myocardial Infarction, run by Beijing Sungen Biomedical Technology Co., Ltd 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 13 Jul 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Gao, Doctor (010-50973600 ext. 010-50973600, wei.gao@sungenbiomed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass) (time frame: Day 4 post-dosing). 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 13 Jul 2026.