A Study Evaluating the Stability and Efficacy of IMC-001 for Injection on Atherosclerotic Plaques in Patients With ACS.
Status:
RECRUITING
Trial end date:
2026-06-30
Target enrollment:
Participant gender:
Summary
A randomized, double-blind, placebo-controlled, multiple-dose escalation IIT clinical study to evaluate the efficacy and safety of injectable IMC-001 in patients with recent acute coronary syndrome (ACS) who are receiving optimal medical therapy after PCI treatment. Two dose groups: 1.0mg/kg and 1.5mg/kg are planned, and if the 1.0mg/kg group is safe and tolerated, it can be upgraded to a higher dose after discussion by DSMB. Fifteen subjects were enrolled in each dose group, including 10 in the experimental group and 5 in the control group. The experimental group received IMC-001 and optimal drug treatment, and a total of 20 subjects were included, and the control group was given placebo and optimal drug treatment, and a total of 10 subjects were included.
Phase:
PHASE2
Details
Lead Sponsor:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Collaborators:
ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. RenJi Hospital The First Affiliated Hospital of Nanyang Medical College