Sponsor study identifier
interventional
52
1 country
11
Study Start
April 4, 2023
Actual (reported)Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2023
Actual (reported)April 3, 2023
Actual (reported)April 4, 2023
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Through study completion, Day 60
Change in oxygenation index (OI).
Through study completion, Day 60
Change in ratio of arterial oxygen partial pressure to fractional inspired oxygen.
Through study completion, Day 60
Change in static compliance.
Through study completion, Day 60
Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days.
Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days.
Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).
Intravenous infusion
Intravenous infusion
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
University of Maryland - Baltimore Washington Medical Center
Ritu Lal, PhD, MS
GEn1E Lifesciences
First Submitted
February 24, 2023
First Posted
April 3, 2023
Study Start
April 4, 2023
KL₄Surfactant Treatment in Patients With ARDS
Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Glen Burnie, Maryland, 21061, United States
Ocean Springs Hospital
Ocean Springs, Mississippi, 39564, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 23, 2026
Record last verified: 2026-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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