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
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, 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.
• Aged between 18 and 75 years old, male or female;
• Patients with recent (within 30 days prior to enrollment) who have had acute coronary syndrome;
• CTA examination of the presence of at least one measurable target vessel segment in the coronary artery, and the following two conditions must be met at the same time: the total volume of plaques with calcified volume accounting for \<50%, and the presence of low-density attenuated plaques (LAP) that meet the definition of CTA;
• High sensitivity C-reactive protein (hsCRP) ≥2.0 mg/L;
• Subjects should take effective contraceptive measures to avoid pregnancy or impregnation of their partner during the period of taking the study drug until 6 months after stopping the drug;
• Subjects understand and comply with the study process, participate voluntarily, and sign the informed consent form..