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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
GEn-1124
DrugIntravenous infusion
Placebo
DrugIntravenous infusion
Treatment groups
52 Participants
are divided into 4 treatment groupsGroup A: Part 1 Cohort 1: GEn-1124Experimental treatment 1 intervention
Group B: Part 1 Cohort 2: GEn-1124Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Group D: Part 2: GEn-1124Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124
* Incidence (frequency over time) of serious adverse events (SAEs) unexpected in ARDS patients. * Incidence (frequency over time) of treatment-emergent adverse events (TEAE).
Time frame
Through study completion, Day 60Other outcomes
1
Change in oxygenation index (OI).
Oxygenation Index is calculated as PAW × FiO2 × 100 / SpO2 where PAW is product of mean airway pressure (PAW), FiO2 is fraction of inspired oxygen, and SpO2 is pulse oxygen saturation (as long as the lowest SpO2 measurement for the day was \< 97%).
Time frame
Through study completion, Day 602
Change in ratio of arterial oxygen partial pressure to fractional inspired oxygen.
Ratio of arterial oxygen partial pressure to fractional inspired oxygen is calculated as PaO2 / FiO2 where PaO2 indicates arterial oxygen partial pressure and FiO2 indicates fraction of inspired oxygen. All values are derived from ventilator parameters and arterial blood gas.
Time frame
Through study completion, Day 603
Change in static compliance.
Static compliance is calculated as the tidal volume divided by the difference between airway plateau pressure and end-expiratory pressure (Pplat - PEEP) where Plat is airway plateau pressure and PEEP is positive end-expiratory pressure. All values are derived from ventilator parameters.
Time frame
Through study completion, Day 604
Change in dynamic compliance.
Dynamic compliance is calculated as the tidal volume divided by the difference between peak inspiratory pressure and end-expiratory pressure (PIP - PEEP) where Plat is airway plateau pressure and PEEP is positive end-expiratory pressure. All values are derived from ventilator parameters.
Time frame
Through study completion, Day 60Sponsors and contacts
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Source ClinicalTrials.gov