NCT04225533

SP16 Inflammatory Response Inhibition Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Serpin Pharma, LLC · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• Inflammation

Interventions

Type	Name	Description
DRUG	SP16	All patients will receive a single dose of SP16

Timeline

• Start date: 2020-02-24
• Primary completion: 2021-01-04
• Completion: 2021-12-21
• First posted: 2020-01-13
• Last updated: 2023-01-30
• Results posted: 2023-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study