A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myoca… (NCT07091929) | Clinical Trial Compass
CompletedPhase 1
A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myocardial Infarction
China38 participantsStarted 2025-01-20
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. Individuals with the following medical histories:
✕. Myocardial infarction and coronary revascularization
✕. Cardiopulmonary resuscitation
✕. Stroke within 6 months before the first dose
What they're measuring
1
Adverse events (AE), Serious adverse events (SAE)
Timeframe: From randomisation to end-of-study (up to 30 days)
2
Recommended Phase 2 dose (RP2D)
Timeframe: From randomisation to end-of-study (up to 30 days)