Evaluation of FDY-5301 in Major Trauma Patients in ICU

Exclusion Criteria

• •1. Likely to die within 48 hrs from time of screening
• •2. 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
• •3. Evidence of nonreversible spinal cord injury
• •4. Bilateral femoral fractures
• •5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative serum pregnancy test prior to randomization.
• •6. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
• •7. Known allergy to iodine
• •8. Chronic renal disease requiring dialysis
• •9. Body mass index (BMI) \>40 kg/m2 or \<16 kg/m2
• •10. Body weight (BW) \>140 kg (or \>309 lb)
• •11. History or presence of debilitating neurologic or other neuromuscular disease (e.g., spina bifida, amyotrophic lateral sclerosis, multiple sclerosis) at time of randomization
• •12. Current metastatic cancer
• •13. Solid organ transplant recipient
• •14. 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.)
• •15. Use of systemic corticosteroids, immunomodulators, or oncologic chemotherapy within 6 months of randomization (inhaled and topical steroids are allowed)
• •16. Use of investigational drugs or devices within 30 days of randomization
• •17. Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301