A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
NCT ID: NCT05795465
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
52 participants
INTERVENTIONAL
2023-04-04
2026-12-31
Brief Summary
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Detailed Description
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GEn-1124 or placebo will be administered as a 2-hour IV infusion as early as possible after ARDS diagnosis. Participants will receive a second dose approximately 8 hours after the first and will continue BID for the remaining schedule (Days 2-5). Follow-up will be for a total of 60 days after the first dose or death (whichever comes first).
An independent Safety Review Committee (SRC) will be responsible for reviewing data throughout the study.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Part 1 Cohort 1: GEn-1124
Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days.
GEn-1124
Intravenous infusion
Part 1 Cohort 2: GEn-1124
Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days.
GEn-1124
Intravenous infusion
Placebo
Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).
Placebo
Intravenous infusion
Part 2: GEn-1124
Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days.
GEn-1124
Intravenous infusion
Interventions
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GEn-1124
Intravenous infusion
Placebo
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent .
3. Dosing as early as possible after first meeting ARDS 2023 Global definition.
4. Acceptable method of birth control.
Exclusion Criteria
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 with immunosuppressant drugs 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. Subjects with known:
1. New York Heart Association Class IV heart disease; or
2. Acute Coronary Syndrome within the past 30 days (e.g., myocardial infarction, unstable angina) or dosing; or
3. Cardiac arrest within 30 days of dosing with sequelae likely to increase mortality.
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. Subject has been on mechanical ventilation for more than 7 days at time of dosing.
17. Burn victims currently undergoing treatment for \>40% total body surface area (TBSA) involvement or for known airway inhalation injury.
18. Neuromuscular disease that could impact ability to wean from mechanical ventilation.
19. 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).
20. Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.
21. Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.
22. 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.
18 Years
85 Years
ALL
No
Sponsors
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GEn1E Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Ritu Lal, PhD, MS
Role: STUDY_DIRECTOR
GEn1E Lifesciences
Locations
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Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
University of Maryland - Baltimore Washington Medical Center
Glen Burnie, Maryland, United States
Ocean Springs Hospital
Ocean Springs, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
The Mount Sinai Hospital
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Countries
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Central Contacts
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Related Links
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GEn1E Lifesciences
Other Identifiers
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GEn-1124-002
Identifier Type: -
Identifier Source: org_study_id
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