A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
ConditionRespiratory Distress Syndrome, Acute
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGEn1E Lifesciences
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GEn-1124
- Placebo
Treatment groups
52 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov