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Acute Myocardial Infarction (AMI) is an acute ischemic necrosis that occurs following acute stenosis or occlusion of the coronary arteries, and it is associated with a high morbidity and mortality rate. Acute myocardial infarction typically occurs in middle-aged and elderly individuals, according to the American Heart Association, with the average age of first occurrence being 65.1 years for men and 72.0 years for women. Myocardial infarction (MI) has a significant impact on global health, affecting over 7 million people worldwide annually. In addition, MI can impose a substantial economic burden on society and families. The research study is a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Pharmacodynamics Profile, and Immunogenicity of SGC001 in Healthy Adult Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGC001 | Experimental | Administration should be initiated as early as possible, with a single intravenous injection completed within 6 hours of disease onset. |
|
| Placebo | Placebo Comparator | Administration should be initiated as early as possible, with a single intravenous injection completed within 6 hours of disease onset. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGC001 | Drug | In this study, 6 dose groups are planned. 8 subjects are enrolled in each group. A total of 48 subjects will be enrolled. The administration method for each group is as follows: The drug SGC001 should be administered once via intravenous injection within 6 hours and the administration time 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Adverse events (AEs) | From randomisation to end-of-study (up to 57 days) |
| Serious adverse events (SAEs) | Serious adverse events (SAEs) | From randomisation to end-of-study (up to 57 days) |
| ECG QT Interval | ECG QT Interval | From randomisation to end-of-study (up to 57 days) |
| Number of participants with Laboratory tests | hematology, blood chemistry, urinalysis, and coagulation | From randomisation to end-of-study (up to 57 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) | Maximum Concentration (Cmax) | Day 1-Day 4, Day 6, Day 8-Day 57 |
| Time to maximum concentration (Tmax) | time to maximum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Lin, Ph.D | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital Capital Medical University | Beijing | Beijing Municipality | 100013 | China |
The individual participant data(IPD) will be shared if necessary
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| ID | Term |
|---|---|
| D056988 | Anterior Wall Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Placebo | Drug | In this study, 6 dose groups are planned. 8 subjects are enrolled in each group. A total of 48 subjects will be enrolled. The administration method for each group is as follows: The drug placebo should be administered once via intravenous injection within 6 hours and the administration time 10 minutes. |
|
| Day 1-Day 4, Day 6, Day 8-Day 57 |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable time point postdose (AUC0-t) | Area under the plasma concentration-time curve from time 0 to the last quantifiable time point postdose (AUC0-t) | Day 1-Day 4, Day 6, Day 8-Day 57 |
| 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) | Day 1-Day 4, Day 6, Day 8-Day 57 |
| Elimination half-life (t1/2) | Elimination half-life (t1/2) | Day 1-Day 4, Day 6, Day 8-Day 57 |
| Elimination rate constant (λz) | Elimination rate constant (λz) | Day 1-Day 4, Day 6, Day 8-Day 57 |
| Interleukin-6(IL-6) [PD endpoints] | Interleukin-6(IL-6) | Day 1-Day 2,Day 4,Day 8-Day 22 |
| Tumor necrosis factor-α(TNF-α)[PD endpoints] | Tumor necrosis factor-α(TNF-α) | Day 1-Day 2,Day 4,Day 8-Day 22 |
| Immunoglobulin G (IgG)[PD endpoints] | Immunoglobulin G (IgG) | Day 1-Day 2,Day 4,Day 8-Day 22 |
| Interleukin-1 β (IL-1 β)[PD endpoints] | Interleukin-1 β (IL-1 β) | Day 1-Day 2,Day 4,Day 8-Day 22 |
| Qualitative detection of anti-drug antibodies in serum(Anti-drug antibody (ADA)) | Qualitative detection of anti-drug antibodies in serum, followed by calculation of the positivity rate as the number of positive samples divided by the total number of samples | Day 1,Day 8-Day 15,Day 29-Day 57 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |