NCT07091929

A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myocardial Infarction

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Beijing Sungen Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anterior Myocardial Infarction

Interventions

Type	Name	Description
DRUG	SGC001	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.
DRUG	Placebo	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.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-07-18
• Completion: 2025-07-18
• First posted: 2025-07-29
• Last updated: 2026-01-12

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated drug study