CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
FDY-5301 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03470441
NCT03470441Phase 2Completed
CompareCT.gov

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

Faraday Pharmaceuticals, Inc.·interventional·Posted Mar 20, 2018·Updated Jan 16, 2026

In Brief

A Phase 2 clinical trial evaluating FDY-5301 and Placebo for Acute Myocardial Infarction and STEMI. Completed, enrolled 120 participants across 23 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myocardial Infarction, STEMI
CountriesHungary, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 20, 2018
Enrollment StartOct 27, 2017
Primary CompletionJul 14, 2018
Study CompletionJan 3, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.3 years ago

Interventions

FDY-5301drug

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.

Placeboother

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.