Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGC001 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE), Serious adverse events (SAE) | Adverse events (AE), Serious adverse events (SAE) | From randomisation to end-of-study (up to 30 days) |
| Recommended Phase 2 dose (RP2D) | Determination of the Recommended Phase II Dose | From randomisation to end-of-study (up to 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Concentration (Cmax) | Peak Concentration (Cmax) | From randomisation to end-of-study (up to 30 days) |
| Time to Maximum Concentration (Tmax) | Time to Maximum Concentration (Tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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);
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang, Bachelor | The Second Affiliated Hospital of Harbin Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital Capital Medical University | Beijing | Beijing Municipality | 100013 | China | ||
| The 2nd Affiliated Hospital of Harbin Medical University |
The individual participant data (IPD) will be shared when necessary
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D056988 | Anterior Wall Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 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. |
|
| 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) | 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) | From randomisation to end-of-study (up to 30 days) |
| Elimination half-life (t1/2) | Elimination half-life (t1/2) | From randomisation to end-of-study (up to 30 days) |
| Elimination rate constant (λz) | Elimination rate constant (λz) | From randomisation to end-of-study (up to 30 days) |
| Clearance (CL) | Clearance (CL) | From randomisation to end-of-study (up to 30 days) |
| Volume of distribution (Vz) | Volume of distribution (Vz) | From randomisation to end-of-study (up to 30 days) |
| Myocardial infarction area percentage[Efficacy endpoints] | Ratio of infarct area to left ventricular area | From randomisation to end-of-study (up to 30 days) |
| Absolute myocardial infarction area | Absolute myocardial infarction area | From randomisation to end-of-study (up to 30 days) |
| Microvascular occlusion area | Microvascular occlusion area | From randomisation to end-of-study (up to 30 days) |
| Left ventricular ejection fraction (LVEF)[Efficacy endpoints] | Left ventricular ejection fraction (LVEF) | From randomisation to end-of-study (up to 30 days) |
| Left ventricular end-systolic volume (LVESV)[Efficacy endpoints] | Left ventricular end-systolic volume (LVESV) | From randomisation to end-of-study (up to 30 days) |
| Left ventricular end-diastolic volume (LVEDV)[Efficacy endpoints] | Left ventricular end-diastolic volume (LVEDV) | 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) | From randomisation to end-of-study (up to 30 days) |
| High-sensitivity troponin I (hsTnI)[Efficacy endpoints] | High-sensitivity troponin I (hsTnI) | From randomisation to end-of-study (up to 30 days) |
| Survival[Efficacy endpoints] | Survival | 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 | From randomisation to end-of-study (up to 30 days) |
| Harbin |
| Heilongjiang |
| 150086 |
| China |
| Linfen Central Hospital | Linfen | Shanxi | 041099 | China |
| Teda International Cardiovascular Hospital | Tianjin | Tianjin Municipality | 300457 | China |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |