NCT04430283

Evaluation of FDY-5301 in Major Trauma Patients in ICU

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 for the Prevention and Treatment of ICU Acquired Weakness in Major Trauma Patients.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Faraday Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The purpose of the trial is to evaluate the efficacy, safety, and PK of FDY-5301 compared to placebo in trauma ICU patients at risk of ICUAW. Muscle wasting occurs rapidly after major trauma and is often associated with multi-organ failure lasting from a few weeks to a long term disability. It is believed that FDY-5301 may help prevent or treat muscle weakness and organ dysfunction in major trauma patients. Approximately 252 subjects will be randomized (1:1:1) to receive up to 7 daily bolus IV doses of FDY-5301 at 1 mg/kg or 2 mg/kg, or volume-matched placebo. To ensure equal representation in each group, the randomization will be stratified by the presence or absence of any pelvic or lower limb fractures. All subjects who satisfy the eligibility criteria will be randomly allocated to one of three treatment groups (FDY-5301 low dose, FDY-5301 high dose, or placebo). All subjects will be followed for 6 months. This study will be conducted globally.

Conditions

• ICU Acquired Weakness

Interventions

Type	Name	Description
DRUG	FDY-5301	FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml.
OTHER	Placebo	Placebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline.

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-03-04
• Completion: 2022-03-04
• First posted: 2020-06-12
• Last updated: 2023-06-13
• Results posted: 2023-06-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study