A Study of GEn-1124 in Subjects with Acute Respiratory Distress Syndrome (ARDS)

Eligibility Criteria

• 1. Male or female subject between the ages of 18 and 80 years old, inclusive.
• 2. Written informed consent .
• 3. Dosing as early as possible after first meeting ARDS 2023 Global definition.
• 4. Acceptable method of birth control.
• 1. Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.
• 2. Pregnant or breastfeeding
• 3. Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.
• 4. Active malignancy (other than non-melanoma skin cancer) requiring treatment within the last 3 months or within the last 6 months if an anti-B cell antibody was received.
• 5. Any other irreversible disease or condition for which 6-month mortality is estimated to be \>50%.
• 6. Moderate to severe liver failure.
• 7. Estimated glomerular filtration rate (eGFR) \<10 mL/min/1.73 m2 or requiring dialysis at screening.
• 8. Acute Left ventricular failure or congestive heart failure, defined as New York Heart Association Class IV.
• 9. Severe chronic respiratory disease with continuous home oxygen \>2 liters per minute (LPM) or \>28% (adjusted for altitude); and/or home noninvasive ventilation (except for the treatment of obstructive sleep apnea).
• 10. Poly-traumatic injury resulting in significant blood loss and/or likely to require major surgery within the study period, or subject condition that would interfere with study procedures.
• 11. History of any type of solid organ or cellular transplant.
• 12. Receiving immunosuppressive therapy for solid organ or hematopoietic cancer, transplant anti-rejection medication, and/or other chronic conditions.
• 13. Moribund subject not expected to survive 24 hours.
• 14. Do not resuscitate (DNR) status.
• 15. World Health Organization (WHO) functional class III or IV pulmonary hypertension.
• 16. Burn victims currently undergoing treatment for \>20% total body surface area (TBSA) involvement or for known airway inhalation injury.
• 17. Neuromuscular disease that could impact ability to wean from mechanical ventilation.
• 18. History of tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of Screening of a positive TB test).
• 19. Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.
• 20. Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.
• 21. Any other medical, psychiatric, or social condition that, in the opinion of the investigator, is likely to unfavorably alter the risk-benefit of subject participation, to interfere with protocol compliance, or to confound safety.