NCT06533358

A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI

An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI.

Detailed description

MT1002 is a novel 32-amino acid synthetic peptide aimed to combine molecular functions of both a direct thrombin inhibitor and a platelet glycoprotein IIb/IIIa receptor antagonist, indicated for use as an antithrombotic and anticoagulant in patients with ACS and in patients undergoing PCI. This study is an Open-label, sequential dose escalation/de-escalation clinical trial of MT1002 in subjects with acute coronary syndrome undergoing PCI. First dose cohort is 0.60 mg/kg (initial loading dose, intravenous bolus) + 1.2 mg/kg/h\*4 h (maintenance dose, intravenous infusion). The Safety Review Committee makes decisions on subsequent dose adjustments. Dose escalation/de-escalation and stopping rules have been put in place to ensure the safety of the patients in this study.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	MT1002 Injection	MT1002 is infused once only, once for 4h. MT1002 is for subjects with acute coronary syndrome undergoing PCI

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-12-01
• Completion: 2025-07-01
• First posted: 2024-08-01
• Last updated: 2024-08-01

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study