SP16 Inflammatory Response Inhibition Trial

Phase 1

Completed

• Conditions: Myocardial Infarction; Inflammation
• Interventions: Drug: SP16

• Registration Number: NCT04225533
• Lead Sponsor: Serpin Pharma, LLC

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-02-24
• Primary Completion: 2021-01-04
• Study Completion: 2021-12-21
• Disposition First Submitted: 2022-01-07
• Results First Submitted: 2022-12-08
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-04
• Disposition First Submitted QC: 2023-01-04
• Last Update Submitted: 2023-01-04
• Results First Posted: 2023-01-30
• Disposition First Posted: 2023-01-30
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP16	SP16	Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) for C-reactive Protein (CRP)	Baseline, 72 hours, 14 days	This study will evaluate the anti-inflammatory effect of SP16 by calculating the AUC for CRP. This is done by measuring CRP at baseline, 72 hours, and 14 days. The AUC will then be compared to historical controls to evaluate whether or not SP16 reduces the AUC for CRP.

Secondary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB)	72 hours	This study will estimate the infarct size based upon area under the curve (AUC) for creatine-kinase myocardial band (CK-MB). The AUC calculation will come from CK-MB levels drawn during usual care. The infarct size will then be compared to historical controls to evaluate whether or not SP16 reduces the infarct size.
Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days	365 days	Patients will undergo transthoracic echocardiography at baseline and 365 days to evaluate the change in LVEF.
Diagnosis of Heart Failure	365 days	Number of participants diagnosed with heart failure at 1 year follow up

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States