A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
- Conditions
- Respiratory Distress Syndrome, Acute
- Interventions
- Drug: Placebo
- Registration Number
- NCT05795465
- Lead Sponsor
- GEn1E Lifesciences
- Brief Summary
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.
- Detailed Description
Randomized , double-blind, placebo controlled, dose escalation study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GEn1124.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- Male or female subject between the ages of 18 and 80 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 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.
- Acute Left ventricular failure or congestive heart failure, defined as New York Heart Association Class IV.
- 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.
- Burn victims currently undergoing treatment for >20% 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 Cohort 1: GEn-1124 GEn-1124 Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days. Part 1 Cohort 2: GEn-1124 GEn-1124 Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days. Part 2: GEn-1124 GEn-1124 Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days. Placebo Placebo Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Medstar Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Ocean Springs Hospital
🇺🇸Ocean Springs, Mississippi, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States