A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
Public ClinicalTrials.gov record NCT05795465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Two-Part Study to Evaluate the Safety and Tolerability of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05795465
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2023
- Primary completion
- Sep 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Jun 22, 2026
2023 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Withdrawn |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Withdrawn |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | Recruiting |
| University of Maryland - Baltimore Washington Medical Center | Glen Burnie | Maryland | 21061 | Recruiting |
| Ocean Springs Hospital | Ocean Springs | Mississippi | 39564 | Completed |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Withdrawn |
| Cooper University Hospital | Camden | New Jersey | 08103 | Recruiting |
| The Mount Sinai Hospital | New York | New York | 10029 | Withdrawn |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Houston Methodist Hospital | Houston | Texas | 77030 | Withdrawn |
| Intermountain Medical Center | Murray | Utah | 84107 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05795465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2026 · Synced Sep 28, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05795465 live on ClinicalTrials.gov.