SGC001
DrugThe 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.
NCT Number: NCT07091929
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Beijing Anzhen Hospital Capital Medical University, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From randomisation to end-of-study (up to 30 days)
Adverse events (AE), Serious adverse events (SAE)
Time frame: From randomisation to end-of-study (up to 30 days)
Determination of the Recommended Phase II Dose
Time frame: From randomisation to end-of-study (up to 30 days)
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)
Ratio of infarct area to left ventricular area
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)
Time frame: From randomisation to end-of-study (up to 30 days)
Left ventricular end-systolic volume (LVESV)
Time frame: From randomisation to end-of-study (up to 30 days)
Left ventricular end-diastolic volume (LVEDV)
Time frame: From randomisation to end-of-study (up to 30 days)
Creatine kinase isoenzyme MB mass (CK-MBmass)
Time frame: From randomisation to end-of-study (up to 30 days)
High-sensitivity troponin I (hsTnI)
Time frame: From randomisation to end-of-study (up to 30 days)
Survival
Time frame: From randomisation to end-of-study (up to 30 days)
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
Beijing Sungen Biomedical Technology Co., Ltd
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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