A Phase 2, Two-Part Study to Evaluate the Safety and Tolerability of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
GEn1E Lifesciences
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.
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 thr…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subject between the ages of 18 and 85 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: 1. 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 tre…
Interventions
- DrugGEn-1124
Intravenous infusion
- DrugPlacebo
Intravenous infusion
Locations (11)
- Medstar Washington Hospital CenterWashington D.C., District of Columbia
- University of Kansas Medical CenterKansas City, Kansas
- University of Maryland Medical CenterBaltimore, Maryland
- University of Maryland - Baltimore Washington Medical CenterGlen Burnie, Maryland
- Ocean Springs HospitalOcean Springs, Mississippi
- Washington University School of MedicineSt Louis, Missouri