Evaluation of FDY-5301 in Major Trauma Patients in ICU

NCT ID: NCT04430283

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2022-03-04

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)

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

FDY-5301 Low Dose (1 mg/kg)

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.

Group Type: EXPERIMENTAL

FDY-5301

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

FDY-5301

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

FDY-5301

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years

2. Major trauma defined as:

1. thoracic and/or abdominal and/or pelvic injury

2. necessitating admission to ICU with ventilation anticipated for at least 24 hrs

3. 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

3. 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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faraday Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harbor-UCLA Medical Center

Torrance, California, United States

University of Florida Health Shands Hospital

Gainesville, Florida, United States

Massachusetts General Hospital, Harvard Medical School

Boston, Massachusetts, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Harborview

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FDY-5301-203

Identifier Type: -

Identifier Source: org_study_id