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

NCT06788431 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-15

No results posted yet for this study

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

Interventions

DRUG

IMC-001 placebo and optimal medical treatment

Subjects receive IMC-001 placebo administered by injection and also receive optimal medical treatment.

DRUG

IMC-001 and Optimal medical treatment

Subjects receive IMC-001 administered by injection and also receive optimal medical treatment.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

    collaborator OTHER

  • The First Affiliated Hospital of Nanyang Medical College

    collaborator UNKNOWN

  • ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

    lead OTHER

Principal Investigators

  • Jun Pu, M.D. · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-10-30
Completion
2026-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788431 on ClinicalTrials.gov