NCT05795465 · GEn1E Lifesciences
A Study of GEn-1124 in Subjects with Acute Respiratory Distress Syndrome (ARDS)
What this study is about
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and how well patients handle the treatment 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.
View original scientific description
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.
Interventions
DRUG
GEn-1124
Intravenous infusion
DRUG
Placebo
Intravenous infusion
Primary outcome measures
To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124
Time frame: Through study completion, Day 60
* Incidence (frequency over time) of serious adverse events (SAEs) unexpected in ARDS patients. * Incidence (frequency over time) of treatment-emergent adverse events (TEAE).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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 fail
Where
- Washington D.C., District of Columbia
- Kansas City, Kansas
- Baltimore, Maryland
- Glen Burnie, Maryland
- Ocean Springs, Mississippi
- St Louis, Missouri
- Camden, New Jersey
- New York, New York
- Cleveland, Ohio
- Houston, Texas
- Murray, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations