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drugset / Trial / NCT04430283

Evaluation of FDY-5301 in Major Trauma Patients in ICU

NCT04430283 ↗

Phase 2 Terminated 8 enrolled Faraday Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW)

Timeline

Start
2021-09-20
Primary completion
2022-03-04
Completion
2022-03-04

Outcome

Outcome not reported

Stopped: “The study was terminated because of difficulty identifying patients that met the inclusion criteria, as well as logistical difficulties in opening clinical ICU study sites.”

Drugs

EvaluationDrugModalityDoseRoute
Subject FDY-5301 Small molecule 1 mg/kg Intravenous
Subject FDY-5301 Small molecule 2 mg/kg Intravenous

Indications

myopathy