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

Exclusion Criteria25

• Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.
• Pregnant or breastfeeding
• Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.
• Active malignancy (other than non-melanoma skin cancer) requiring treatment with immunosuppressant drugs within the last 3 months or within the last 6 months if an anti-B cell antibody was received.
• Any other irreversible disease or condition for which 6-month mortality is estimated to be >50%.
• Moderate to severe liver failure.
• Estimated glomerular filtration rate (eGFR) <10 mL/min/1.73 m2 or requiring dialysis at screening.
• Subjects with known:
• New York Heart Association Class IV heart disease; or
• Acute Coronary Syndrome within the past 30 days (e.g., myocardial infarction, unstable angina) or dosing; or
• Cardiac arrest within 30 days of dosing with sequelae likely to increase mortality.
• 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).
• 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.
• History of any type of solid organ or cellular transplant.
• Receiving immunosuppressive therapy for solid organ or hematopoietic cancer, transplant anti-rejection medication, and/or other chronic conditions.
• Moribund subject not expected to survive 24 hours.
• Do not resuscitate (DNR) status.
• World Health Organization (WHO) functional class III or IV pulmonary hypertension.
• Subject has been on mechanical ventilation for more than 7 days at time of dosing.
• Burn victims currently undergoing treatment for >40% total body surface area (TBSA) involvement or for known airway inhalation injury.
• Neuromuscular disease that could impact ability to wean from mechanical ventilation.
• 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).
• Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.
• Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.
• 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.