NCT06788431

A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.

A Two-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Investigator-Initiated Trial (IIT) Evaluating the Safety and Preliminary Efficacy of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A two-center, randomized, double-blind, placebo-controlled, dose-escalation IIT clinical study evaluating the safety and preliminary efficacy of injectable IMC-001 in improving atherosclerotic plaque stability in patients with acute coronary syndrome. The plan is to conduct 2 dose groups, with 9 subjects enrolled in each group, including 6 in the treatment group and 3 in the control group. The treatment group will receive IMC-001 along with optimal drug therapy, with a total of 12 subjects included, while the control group will receive a placebo along with optimal drug therapy, with a total of 6 subjects included.

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
DRUG	IMC-001 and Optimal medical treatment	Subjects receive IMC-001 administered by injection and also receive optimal medical treatment.
DRUG	IMC-001 placebo and optimal medical treatment	Subjects receive IMC-001 placebo administered by injection and also receive optimal medical treatment.

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2025-01-23
• Last updated: 2026-04-15

Locations

2 sites across 1 country: China