Actively Recruiting
A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
Led by GEn1E Lifesciences · Updated on 2025-10-22
52
Participants Needed
11
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days.
CONDITIONS
Official Title
A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subject between the ages of 18 and 85 years old, inclusive.
- Written informed consent.
- Dosing as early as possible after first meeting ARDS 2023 Global definition.
- Acceptable method of birth control.
You will not qualify if you...
- 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 immunosuppressant treatment within last 3 months or anti-B cell antibody treatment within last 6 months.
- Any other irreversible disease or condition with estimated 6-month mortality over 50%.
- Moderate to severe liver failure.
- Estimated glomerular filtration rate (eGFR) less than 10 mL/min/1.73 m2 or requiring dialysis at screening.
- Known New York Heart Association Class IV heart disease.
- Acute Coronary Syndrome within past 30 days or dosing.
- Cardiac arrest within 30 days of dosing with likely increased mortality.
- Severe chronic respiratory disease requiring continuous home oxygen over 2 liters per minute or home noninvasive ventilation (except for obstructive sleep apnea).
- Poly-traumatic injury causing significant blood loss or likely major surgery during study period.
- History of solid organ or cellular transplant.
- Receiving immunosuppressive therapy for cancer, transplant rejection, or chronic conditions.
- Moribund subject not expected to survive 24 hours.
- Do not resuscitate (DNR) status.
- WHO functional class III or IV pulmonary hypertension.
- Mechanical ventilation for more than 7 days at dosing.
- Burn victims with treatment for over 40% total body surface area or known airway inhalation injury.
- Neuromuscular disease impacting ability to wean from mechanical ventilation.
- History or treatment of tuberculosis or latent TB within 3 months of screening.
- Active Hepatitis B, untreated Hepatitis C, or positive HIV screen.
- Use of investigational drug or device within last 30 days or 5 half-lives.
- Any other medical, psychiatric, or social condition likely to affect safety, compliance, or risk-benefit per investigator's opinion.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Withdrawn
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
3
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
University of Maryland - Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
5
Ocean Springs Hospital
Ocean Springs, Mississippi, United States, 39564
Completed
6
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
8
The Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
Houston Methodist Hospital
Houston, Texas, United States, 77030
Withdrawn
11
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
Research Team
R
Ritu Lal, PhD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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