NCT07079618

A Research Study to Evaluate the Safety and Tolerability of SGC001 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Beijing Sungen Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Anterior Myocardial Infarction

Interventions

Type	Name	Description
DRUG	SGC001	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.
DRUG	Placebo	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.

Timeline

• Start date: 2024-08-20
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2025-07-23
• Last updated: 2025-11-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study