NCT06572267

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Mepolizumab low dose group	Meperizumab (0.05 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.
DRUG	Mepolizumab middle dose group	Meperizumab (0.1 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.
DRUG	Mepolizumab high dose group	Meperizumab (0.2 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.
DRUG	Saline	Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-09-01
• Completion: 2027-03-01
• First posted: 2024-08-27
• Last updated: 2026-01-23

Locations

1 site across 1 country: China