SP16 Inflammatory Response Inhibition Trial

Status Completed

Clinical Trial Summary

This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.

Clinical Trial Description

The main hypothesis of this study is that a single subcutaneous administration of SP16 0.2 mg/kg is safe and well tolerated in patients with ST segment elevation myocardial infarction (STEMI) and associated with a reduction in the acute inflammatory response to STEMI, as measured as area-under-the-curve (AUC) for C reactive protein (CRP), the preferred inflammatory marker for cardiovascular risk prognostication. SP16 will be administered subcutaneously as this route has greater ease of administration than intravenous injection. A single dose administration has been selected based upon pre-clinical data and expected clinical use of SP16. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04225533
Study type	Interventional
Source	Serpin Pharma, LLC
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	February 24, 2020
Completion date	December 21, 2021

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SP16 Inflammatory Response Inhibition Trial — SPIRIT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms