Anterior Myocardial InfarctionPhase 1NCT07091929
A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myocardial Infarction
A Phase 1 study testing SGC001 in people with Anterior Myocardial Infarction, run by Beijing Sungen Biomedical Technology Co., Ltd at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anterior Myocardial Infarction
- What is being tested?
- SGC001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 4 sitesChina
- Study dates
- 20 Jan 2025to 18 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18~75 years (both inclusive)
- 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.
- Ability to receive study drug administration within 6 hours of symptom onset, as assessed by the investigator;
- 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;
Who cannot join
- Individuals with the following medical histories:
- Myocardial infarction and coronary revascularization
- Cardiopulmonary resuscitation
- Stroke within 6 months before the first dose
- Aortic dissection
- Individuals who received thrombolytic therapy;
Show all 17Show fewer
- Individuals who have recent febrile infection, requiring systemic treatment;
- Individuals with cardiogenic shock or hemodynamic instability (such as severe arrhythmia), including systolic blood pressure <90 mmHg;
- Individuals with clear diagnosis of acute heart failure (Killip grade ≥ III, Killip grade is detailed in appendix);
- Individuals who cannot undergo cardiovascular magnetic resonance (CMR) testing or are known to be allergic to any radio-contrast agent;
- Individuals who have participated in other drug clinical studies and received other clinical trial drugs within 1 months prior to receiving the investigational drug;
- Individuals with the following medical histories:
- severe liver and renal insufficiency;
- Patients with malignant tumors or previous history of malignant tumors;
- Severe autoimmune disease requiring therapeutic intervention;
- 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;
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, 100013
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Linfen Central Hospital
Linfen, Shanxi, 041099
Teda International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Immunogenicity, and Preliminary Efficacy of SGC001 in Chinese Patients Scheduled to Undergo Percutaneous Coronary Intervention for Anterior ST-segment Elevation Myocardial Infarction
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.
- Conditions
- Anterior Myocardial Infarction
- Being tested
- SGC001, Placebo
- Medical subject headings
- Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGC001Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SGC001 | Experimental | 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. Receives: Drug: SGC001 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE), Serious adverse events (SAE)
Adverse events (AE), Serious adverse events (SAE)
Measured: From randomisation to end-of-study (up to 30 days)
Recommended Phase 2 dose (RP2D)
Determination of the Recommended Phase II Dose
Measured: From randomisation to end-of-study (up to 30 days)
Secondary outcomes (18)
Peak Concentration (Cmax)
Peak Concentration (Cmax)
Measured: From randomisation to end-of-study (up to 30 days)
Time to Maximum Concentration (Tmax)
Time to Maximum Concentration (Tmax)
Measured: From randomisation to end-of-study (up to 30 days)
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)
Measured: From randomisation to end-of-study (up to 30 days)
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)
Measured: From randomisation to end-of-study (up to 30 days)
Elimination half-life (t1/2)
Elimination half-life (t1/2)
Measured: From randomisation to end-of-study (up to 30 days)
Elimination rate constant (λz)
Elimination rate constant (λz)
Measured: From randomisation to end-of-study (up to 30 days)
Clearance (CL)
Clearance (CL)
Measured: From randomisation to end-of-study (up to 30 days)
Volume of distribution (Vz)
Volume of distribution (Vz)
Measured: From randomisation to end-of-study (up to 30 days)
Myocardial infarction area percentage[Efficacy endpoints]
Ratio of infarct area to left ventricular area
Measured: From randomisation to end-of-study (up to 30 days)
Absolute myocardial infarction area
Absolute myocardial infarction area
Measured: From randomisation to end-of-study (up to 30 days)
Microvascular occlusion area
Microvascular occlusion area
Measured: From randomisation to end-of-study (up to 30 days)
Left ventricular ejection fraction (LVEF)[Efficacy endpoints]
Left ventricular ejection fraction (LVEF)
Measured: From randomisation to end-of-study (up to 30 days)
Left ventricular end-systolic volume (LVESV)[Efficacy endpoints]
Left ventricular end-systolic volume (LVESV)
Measured: From randomisation to end-of-study (up to 30 days)
Left ventricular end-diastolic volume (LVEDV)[Efficacy endpoints]
Left ventricular end-diastolic volume (LVEDV)
Measured: From randomisation to end-of-study (up to 30 days)
Creatine kinase isoenzyme MB mass (CK-MBmass)[Efficacy endpoints]
Creatine kinase isoenzyme MB mass (CK-MBmass)
Measured: From randomisation to end-of-study (up to 30 days)
High-sensitivity troponin I (hsTnI)[Efficacy endpoints]
High-sensitivity troponin I (hsTnI)
Measured: From randomisation to end-of-study (up to 30 days)
Survival[Efficacy endpoints]
Survival
Measured: From randomisation to end-of-study (up to 30 days)
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
Measured: From randomisation to end-of-study (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start20 Jan 2025
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zhang, Bachelor, Study director, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091929
- Sponsor's protocol ID
- SG-SGC001-102
- Status last verified
- Jan 2026
- First submitted
- 24 Jun 2025
- Last updated
- 12 Jan 2026
- Results posted
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Immunogenicity, and Preliminary Efficacy of SGC001 in Chinese Patients Scheduled to Undergo Percutaneous Coronary Intervention for Anterior ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07091929
- Acronym / sponsor ID
- SG-SGC001-102
- Conditions
- Anterior Myocardial Infarction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 29 Jul 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGC001 | Experimental | Drug: SGC001Enrolled 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. |
| Placebo | Placebo comparator | Drug: PlaceboEnrolled 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects aged 18~75 years (both inclusive)
- 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.
- Ability to receive study drug administration within 6 hours of symptom onset, as assessed by the investigator;
- 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;
Key exclusion criteria (17 listed)
- Individuals with the following medical histories:
- Individuals who received thrombolytic therapy;
- Individuals who have recent febrile infection, requiring systemic treatment;
- Individuals with cardiogenic shock or hemodynamic instability (such as severe arrhythmia), including systolic blood pressure <90 mmHg;
- Individuals with clear diagnosis of acute heart failure (Killip grade ≥ III, Killip grade is detailed in appendix);
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 |
|---|---|---|
| SGC001The 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. | Drug | SGC001 |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
Adverse events (AE), Serious adverse events (SAE)
Time frame: From randomisation to end-of-study (up to 30 days)
Adverse events (AE), Serious adverse events (SAE)
Recommended Phase 2 dose (RP2D)
Time frame: From randomisation to end-of-study (up to 30 days)
Determination of the Recommended Phase II Dose
18 secondary outcomes
Peak Concentration (Cmax)
Time frame: From randomisation to end-of-study (up to 30 days)
Time to Maximum Concentration (Tmax)
Time frame: From randomisation to end-of-study (up to 30 days)
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)
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)
Elimination half-life (t1/2)
Time frame: From randomisation to end-of-study (up to 30 days)
Elimination rate constant (λz)
Time frame: From randomisation to end-of-study (up to 30 days)
Clearance (CL)
Time frame: From randomisation to end-of-study (up to 30 days)
Volume of distribution (Vz)
Time frame: From randomisation to end-of-study (up to 30 days)
Myocardial infarction area percentage[Efficacy endpoints]
Time frame: From randomisation to end-of-study (up to 30 days)
Absolute myocardial infarction area
Time frame: From randomisation to end-of-study (up to 30 days)
Microvascular occlusion area
Time frame: From randomisation to end-of-study (up to 30 days)
Left ventricular ejection fraction (LVEF)[Efficacy endpoints]
Time frame: From randomisation to end-of-study (up to 30 days)
Left ventricular end-systolic volume (LVESV)[Efficacy endpoints]
Time frame: From randomisation to end-of-study (up to 30 days)
Left ventricular end-diastolic volume (LVEDV)[Efficacy endpoints]
Time frame: From randomisation to end-of-study (up to 30 days)
Creatine kinase isoenzyme MB mass (CK-MBmass)[Efficacy endpoints]
Time frame: From randomisation to end-of-study (up to 30 days)
High-sensitivity troponin I (hsTnI)[Efficacy endpoints]
Time frame: From randomisation to end-of-study (up to 30 days)
Survival[Efficacy endpoints]
Time frame: From randomisation to end-of-study (up to 30 days)
Qualitative detection of anti-drug antibodies in serum（Anti-drug antibody (ADA)）
Time frame: From randomisation to end-of-study (up to 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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. This study is not recruiting at the moment.
Wei Zhang, Bachelor study director
The Second Affiliated Hospital of Harbin Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGC001 in people with Anterior Myocardial Infarction, run by Beijing Sungen Biomedical Technology Co., Ltd at 4 sites 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE), Serious adverse events (SAE) (time frame: From randomisation to end-of-study (up to 30 days)). The study lists 2 primary outcomes in all. 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 12 Jan 2026.