Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05795465 · ClinicalTrials.gov registry record · Phase 2
A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 study of Respiratory Distress Syndrome, Acute, sponsored by GEn1E Lifesciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 11
- Study locations
NCT05795465: Recruiting Phase 2 study of Respiratory Distress Syndrome, Acute, sponsored by GEn1E Lifesciences.
NCT05795465 is a Phase 2 study of Respiratory Distress Syndrome, Acute that is actively recruiting participants, run by GEn1E Lifesciences. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05795465, a Phase 2 study of Respiratory Distress Syndrome, Acute, is actively recruiting participants, sponsored by GEn1E Lifesciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
* Incidence (frequency over time) of serious adverse events (SAEs) unexpected in ARDS patients. * Incidence (frequency over time) of treatment-emergent adverse events (TEAE).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GEn-1124
Study Locations (11)
Maryland
- University of Maryland Medical Center - Baltimore
- University of Maryland - Baltimore Washington Medical Center - Glen Burnie
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Kansas
- University of Kansas Medical Center - Kansas City
Mississippi
- Ocean Springs Hospital - Ocean Springs
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Cooper University Hospital - Camden
New York
- The Mount Sinai Hospital - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT05795465 shows while recruiting
NCT05795465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Respiratory Distress Syndrome, Acute appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05795465 lists 11 locations in 10 states (Maryland, District of Columbia, Kansas).
Frequently Asked Questions
What is clinical trial NCT05795465 about?
NCT05795465 is a clinical study titled "A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)". 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 tw...
What is the current status of trial NCT05795465?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2023-04-04. Estimated completion is 2026-12.
What conditions does trial NCT05795465 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Acute.
What interventions are being tested in trial NCT05795465?
The interventions under investigation include: Placebo (DRUG), GEn-1124 (DRUG).
Who is sponsoring clinical trial NCT05795465?
This trial is sponsored by GEn1E Lifesciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05795465 being conducted?
This trial has 11 study locations across District of Columbia, Kansas, Maryland, Mississippi, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05795465's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI