Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with chronic coronary syndrome
• Non-target lesions with stenosis ≥50% by visual assessment
• Angina symptoms manageable via antianginal medication
• High attenuation coefficient (≥-70.1 HU) of perivascular adipose tissue (PVAT) around non-target lesions as assessed by coronary CT angiography (CCTA)
• Patients who are able to complete the follow-up and compliant to the prescribed medication
Locations
Other Locations
China
Ling Tao
RECRUITING
Xi'an
Contact Information
Primary
Chao Gao, M.D., Ph.D.
woshigaochao@gmail.com
18629551066
Time Frame
Start Date:2024-10-16
Estimated Completion Date:2026-03-01
Participants
Target number of participants:18
Treatments
Experimental: Mepolizumab low dose group
Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.05 mg/kg, monthly.~Meperizumab 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.
Experimental: Mepolizumab middle dose group
Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.1 mg/kg, monthly.~Meperizumab 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.
Experimental: Mepolizumab high dose group
Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.2 mg/kg, monthly.~Meperizumab 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.