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RECRUITING
NCT07306182
PHASE2

A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction

Sponsor: Beijing Sungen Biomedical Technology Co., Ltd

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of SGC001 injection administered in addition to standard clinical care in Chinese patients with acute anterior ST-segment elevation myocardial infarction (STEMI) who are planned for primary percutaneous coronary intervention (pPCI).

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of SGC001 Injection in Chinese Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction and Planned for Primary Percutaneous Coronary Intervention (pPCI)

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-03-09

Completion Date

2027-10

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

DRUG

SGC001 injection

Dosage: 600mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)

DRUG

SGC001 injection

Dosage: 900mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)

DRUG

Placebo

Dosage: 0mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China