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CompletedNCT07091929Updated Jan 12, 2026

A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myocardial Infarction

A Phase 1 interventional study of SGC001 and Placebo in Anterior Myocardial Infarction, sponsored by Beijing Sungen Biomedical Technology Co., Ltd. Completed at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Beijing Sungen Biomedical Technology Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2025, 1 year 2 months ago, and no results have been posted to the registry.
  • Registered 5 months after the study started (first participant enrolled Jan 2025, registered Jun 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Anterior Myocardial Infarction
03

In context

Anterior Wall Myocardial Infarction

34 studies on the registry are indexed under Anterior Wall Myocardial Infarction; 6 are open to participants now.

This study's enrollment of 38 is below the median of 120 across 27 interventional studies indexed under Anterior Wall Myocardial Infarction.

Browse Anterior Wall Myocardial Infarction studies →

Lead sponsor

Beijing Sungen Biomedical Technology Co., Ltd is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female subjects aged 18\~75 years (both inclusive)
  2. Anterior STEMI, defined as: (a) Persistent chest pain or discomfort > 30 minutes; AND (b) Persistent ST-segment elevation ≥0.1 mV in ≥2 contiguous precordial leads (V1-V6) on the admission ECG, with ≥0.2 mV required in leads V2 and V3; OR, if （a）clinical symptoms are atypical, (c) a positive point-of-care cardiac troponin test is required.
  3. Ability to receive study drug administration within 6 hours of symptom onset, as assessed by the investigator;
  4. Subjects who fully understand the purpose, nature, method, and potential adverse reactions of the trial, and who voluntarily sign the informed consent form and agree to participate in the study;

Exclusion criteria

Exclusion Criteria:

  1. Individuals with the following medical histories:

    1. Myocardial infarction and coronary revascularization
    2. Cardiopulmonary resuscitation
    3. Stroke within 6 months before the first dose
    4. Aortic dissection
  2. Individuals who received thrombolytic therapy;
  3. Individuals who have recent febrile infection, requiring systemic treatment;
  4. Individuals with cardiogenic shock or hemodynamic instability (such as severe arrhythmia), including systolic blood pressure \<90 mmHg;
  5. Individuals with clear diagnosis of acute heart failure (Killip grade ≥ III, Killip grade is detailed in appendix);
  6. Individuals who cannot undergo cardiovascular magnetic resonance (CMR) testing or are known to be allergic to any radio-contrast agent;
  7. Individuals who have participated in other drug clinical studies and received other clinical trial drugs within 1 months prior to receiving the investigational drug;

  8. Individuals with the following medical histories:

    1. severe liver and renal insufficiency;
    2. Patients with malignant tumors or previous history of malignant tumors;
    3. Severe autoimmune disease requiring therapeutic intervention;
  9. Women of childbearing potential (WOCBP) or men who plan to father a child or whose partners plan to become pregnant from screening until 3 months after receiving the investigational product; pregnant or lactating women;
  10. Any other circumstance that, in the judgement of the investigator, may affect the ability of the subject to provide informed consent or to follow the trial protocol, or where the subject's participation in the trial may affect the outcome of the trial or his or her safety.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugSGC001

    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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Adverse events (AE), Serious adverse events (SAE)

    Adverse events (AE), Serious adverse events (SAE)

    Time frame: From randomisation to end-of-study (up to 30 days)

  2. Recommended Phase 2 dose (RP2D)

    Determination of the Recommended Phase II Dose

    Time frame: From randomisation to end-of-study (up to 30 days)

Secondary outcomes

  1. Peak Concentration (Cmax)

    Peak Concentration (Cmax)

    Time frame: From randomisation to end-of-study (up to 30 days)

  2. Time to Maximum Concentration (Tmax)

    Time to Maximum Concentration (Tmax)

    Time frame: From randomisation to end-of-study (up to 30 days)

  3. Area under the plasma concentration-time curve from time zero to the last quantifiable rime point after administration (AUC0-t)

    Area under the plasma concentration-time curve from time zero to the last quantifiable rime point after administration (AUC0-t)

    Time frame: From randomisation to end-of-study (up to 30 days)

  4. Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

    Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

    Time frame: From randomisation to end-of-study (up to 30 days)

  5. Elimination half-life (t1/2)

    Elimination half-life (t1/2)

    Time frame: From randomisation to end-of-study (up to 30 days)

  6. Elimination rate constant (λz)

    Elimination rate constant (λz)

    Time frame: From randomisation to end-of-study (up to 30 days)

  7. Clearance (CL)

    Clearance (CL)

    Time frame: From randomisation to end-of-study (up to 30 days)

  8. Volume of distribution (Vz)

    Volume of distribution (Vz)

    Time frame: From randomisation to end-of-study (up to 30 days)

  9. Myocardial infarction area percentage[Efficacy endpoints]

    Ratio of infarct area to left ventricular area

    Time frame: From randomisation to end-of-study (up to 30 days)

  10. Absolute myocardial infarction area

    Absolute myocardial infarction area

    Time frame: From randomisation to end-of-study (up to 30 days)

  11. Microvascular occlusion area

    Microvascular occlusion area

    Time frame: From randomisation to end-of-study (up to 30 days)

  12. Left ventricular ejection fraction (LVEF)[Efficacy endpoints]

    Left ventricular ejection fraction (LVEF)

    Time frame: From randomisation to end-of-study (up to 30 days)

  13. Left ventricular end-systolic volume (LVESV)[Efficacy endpoints]

    Left ventricular end-systolic volume (LVESV)

    Time frame: From randomisation to end-of-study (up to 30 days)

  14. Left ventricular end-diastolic volume (LVEDV)[Efficacy endpoints]

    Left ventricular end-diastolic volume (LVEDV)

    Time frame: From randomisation to end-of-study (up to 30 days)

  15. Creatine kinase isoenzyme MB mass (CK-MBmass)[Efficacy endpoints]

    Creatine kinase isoenzyme MB mass (CK-MBmass)

    Time frame: From randomisation to end-of-study (up to 30 days)

  16. High-sensitivity troponin I (hsTnI)[Efficacy endpoints]

    High-sensitivity troponin I (hsTnI)

    Time frame: From randomisation to end-of-study (up to 30 days)

  17. Survival[Efficacy endpoints]

    Survival

    Time frame: From randomisation to end-of-study (up to 30 days)

  18. Qualitative detection of anti-drug antibodies in serum（Anti-drug antibody (ADA)）

    Qualitative detection of anti-drug antibodies in serum by ELISA, followed by calculation of the positivity rate as the number of positive samples divided by the total number of samples

    Time frame: From randomisation to end-of-study (up to 30 days)

07

Study locations

4 sites
  • Beijing Anzhen Hospital Capital Medical University
    Beijing, Beijing Municipality 100013, China
  • The 2nd Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 150086, China
  • Linfen Central Hospital
    Linfen, Shanxi 041099, China
  • Teda International Cardiovascular Hospital
    Tianjin, Tianjin Municipality 300457, China
08

References and documents

Individual participant data

Plan to share: No — The individual participant data (IPD) will be shared when necessary

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07091929
Lead sponsor
Beijing Sungen Biomedical Technology Co., Ltd
Responsible party
Sponsor
First posted
Jul 29, 2025
Start date
Jan 20, 2025
Primary completion
Jul 18, 2025
Completion
Jul 18, 2025
Last update
Jan 12, 2026

Study contacts

Wei Zhang, Bachelor
study director · The Second Affiliated Hospital of Harbin Medical University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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