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New treatment option for Respiratory Distress Syndrome, Acute
Official title A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
ClinicalTrials.gov ID: NCT05795465
What this study is testing
What is GEn-1124?
GEn-1124 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for respiratory distress syndrome, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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 likely can't join if
- 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...
- Any other irreversible disease or condition for which 6-month mortality is estimated to be \>50%.
- Moderate to severe liver failure.
See the full eligibility criteria
- 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.
- 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.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Glen Burnie, Maryland, United States
- Ocean Springs, Mississippi, United States
- St Louis, Missouri, United States
- Camden, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Murray, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States; Glen Burnie, Maryland, United States; Ocean Springs, Mississippi, United States; St Louis, Missouri, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.