drugset / Trial / NCT06788431
A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
Phase 0
Recruiting
18 enrolled
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
First Affiliated Hospital of Nanyang Medical College · collabImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. · collabRenJi Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-03-10
- Primary completion
- 2026-10-30
- Completion
- 2026-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMC-001 | Monoclonal antibody | — | Other |