NCT03470441

A Study of Acute Myocardial Infarction Using FDY-5301

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Faraday Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.

Detailed description

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart attack. An experimental drug is one that is being tested and is not approved by the United States Food and Drug Administration (FDA). A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization procedure to clear the blockage in your coronary artery that caused your heart attack. This procedure works well but may not completely prevent some injury to the heart muscle which occurs when the blood supply is initially restored to the heart. This is known as "reperfusion injury". FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in this study at about 20 research sites in the United States and Europe. Each subject's participation is expected to last about 6 months after receiving the study drug. Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups. Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously) during the catheterization procedure. This is a double-blind study so neither the patient nor study personnel will know whether the dose is active drug or placebo until the end of the study.

Conditions

• Acute Myocardial Infarction
• STEMI

Interventions

Type	Name	Description
DRUG	FDY-5301	FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
OTHER	Placebo	Placebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-07-14
• Completion: 2019-01-03
• First posted: 2018-03-20
• Last updated: 2026-01-16
• Results posted: 2021-12-14

Locations

23 sites across 4 countries: United States, Hungary, Poland, United Kingdom

Regulatory

• FDA-regulated drug study