Evaluation of FDY-5301 in Major Trauma Patients in ICU

NCT04430283 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: FDY-5301-203
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief 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)

Conditions

ICU Acquired Weakness

Keywords

ICU acquired weakness, PICS, SIRS; Muscle wasting and weakness; muscle function; quality of life

Outcome Measures

Primary Outcomes (2)

• Chelsea Critical Care Physical Assessment Tool

  Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.

  Day 10 or hospital discharge, whichever occurs first.

• Organ Dysfunction Total Time to Recovery

  Organ dysfunction total time to recovery (TTR) until Day 28

  Day 28 or hospital discharge, whichever occurs first.

Secondary Outcomes (3)

• Medical Research Council Sum Score

  Day 28, or hospital discharge, whichever occurs first

• Sequential Organ Failure Assessment Score

  ICU hospital stay until Day 28 or ICU discharge if earlier

• Overall Survival at Day 28

  Day 28

Study Arms (3)

FDY-5301 Low Dose (1 mg/kg)

EXPERIMENTAL

FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.

Drug: FDY-5301

FDY-5301 High Dose (2 mg/kg)

EXPERIMENTAL

FDY-5301 will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening.

Drug: FDY-5301

Placebo

PLACEBO COMPARATOR

Placebo will be administered intravenously once daily for up to 7 days. Dosage will be determined on a body weight basis, according to treatment assignment and using the subject's body weight (estimated or actual) determined at screening. Other Names: Saline

Other: Placebo

Interventions

FDY-5301 DRUG

FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml.

FDY-5301 High Dose (2 mg/kg); FDY-5301 Low Dose (1 mg/kg)

Placebo OTHER

Placebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Major trauma defined as:
• thoracic and/or abdominal and/or pelvic injury
• necessitating admission to ICU with ventilation anticipated for at least 24 hrs
• hemorrhagic shock defined as systolic blood pressure (SBP) \<90 mmHG requiring blood transfusion or base deficit of at least 6mEq/L pre-hospital arrival or within one hour after hospital arrival
• IRB/IEC-approved consent obtained within 48 hours of first hospital arrival time (i.e., in case of transfers, use time of arrival to first hospital immediately post injury)

You may not qualify if:

• Likely to die within 48 hrs from time of screening
• Any neurological condition that is perceived at the time of hospital admission as an immediate threat to life or incompatible with good functional recovery and where early limitation or withdrawal of therapy is being considered. For example:
• a. Computed tomography imaging showing evidence of traumatic brain injury (TBI), combined with best representative Glasgow Coma Score (GCS) Motor Score of ≤4 at approximately 24 hrs post injury
• Evidence of nonreversible spinal cord injury
• Bilateral femoral fractures
• Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative serum pregnancy test prior to randomization.
• Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
• Known allergy to iodine
• Chronic renal disease requiring dialysis
• Body mass index (BMI) \>40 kg/m2 or \<16 kg/m2
• Body weight (BW) \>140 kg (or \>309 lb)
• History or presence of debilitating neurologic or other neuromuscular disease (e.g., spina bifida, amyotrophic lateral sclerosis, multiple sclerosis) at time of randomization
• Current metastatic cancer
• Solid organ transplant recipient
• Evidence of pre-existing sarcopenia defined as having a pre-trauma Clinical Frailty Score (CFS) of ≥5 or based on clinical judgement (e.g. frail by appearance, cachexia, etc.)

Sponsors & Collaborators

• Faraday Pharmaceuticals, Inc.: lead

Study Sites (5)

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

Massachusetts General Hospital, Harvard Medical School

Boston, Massachusetts, 02114, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Harborview

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Muscular Atrophy; Asthenia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Faraday Pharmaceuticals, Inc.

info@faradaypharma.com

206-492-5310

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects who fulfill all study edibility criteria will be randomized to receive one of the 3 treatments.

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: June 12, 2020
• Study Start: September 20, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-06

Locations

US (5)