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GEn-1124 for ARDS

Phase 2
Recruiting
Research Sponsored by GEn1E Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 9 through 60

Summary

This trial will test if GEn-1124 is safe & tolerable for treating ARDS, given in 2 doses within 48hrs & then twice daily for 5 days.

Who is the study for?
Adults aged 18-80 with a recent diagnosis of ARDS can join this trial. They must be hospitalized, able to consent, and use birth control. Excluded are burn victims with extensive injuries, those with unstable heart disease or severe lung conditions, people in prison or mental health facilities, anyone who's had organ transplants or certain infections like TB and hepatitis.
What is being tested?
The study tests GEn-1124 against a placebo in patients with ARDS. Participants receive an IV infusion within 48 hours of diagnosis followed by twice-daily doses for five days to assess safety and tolerability.
What are the potential side effects?
While the specific side effects of GEn-1124 aren't listed here, common side effects from similar treatments may include reactions at the infusion site, fatigue, potential allergic responses, and gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 9 through 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 9 through 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124
Other study objectives
Change in Euro Quality of Life Health Survey (EQ-5D-5L).
Change in Sequential Organ Failure Assessment (SOFA) score.
Change in Short Form 36 Health Survey Questionnaire (SF-36).
+20 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: GEn-1124Experimental Treatment1 Intervention
Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days.
Group II: Part 1 Cohort 2: GEn-1124Experimental Treatment1 Intervention
Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days.
Group III: Part 1 Cohort 1: GEn-1124Experimental Treatment1 Intervention
Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days.
Group IV: PlaceboPlacebo Group1 Intervention
Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).

Find a Location

Who is running the clinical trial?

GEn1E LifesciencesLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Ritu Lal, PhD, MSStudy DirectorGEn1E Lifesciences
1 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

GEn-1124 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05795465 — Phase 2
Acute Respiratory Distress Syndrome Research Study Groups: Part 1 Cohort 1: GEn-1124, Part 1 Cohort 2: GEn-1124, Placebo, Part 2: GEn-1124
Acute Respiratory Distress Syndrome Clinical Trial 2023: GEn-1124 Highlights & Side Effects. Trial Name: NCT05795465 — Phase 2
GEn-1124 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05795465 — Phase 2
~16 spots leftby Oct 2025
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