Evaluation of FDY-5301 in Major Trauma Patients in ICU

  • End date
    Sep 30, 2023
  • participants needed
  • sponsor
    Faraday Pharmaceuticals, Inc.
Updated on 24 November 2021


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)


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.

Condition ICU Acquired Weakness
Treatment Placebo, FDY-5301
Clinical Study IdentifierNCT04430283
SponsorFaraday Pharmaceuticals, Inc.
Last Modified on24 November 2021


Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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.)
Use of systemic corticosteroids, immunomodulators, or oncologic chemotherapy within 6 months of randomization (inhaled and topical steroids are allowed)
Use of investigational drugs or devices within 30 days of randomization
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note