GEn-1124 for ARDS

Recruiting at7 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: GEn1E Lifesciences

Must not be taking: Immunosuppressants, Anti-rejection meds

Disqualifiers: Active malignancy, Liver failure, Heart failure, Respiratory disease, others

Prior Safety Data

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have used an investigational drug recently, you may not be eligible to participate.

Research Team

Ritu Lal, PhD, MS

Principal Investigator

GEn1E Lifesciences

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent

Dosing as early as possible after first meeting ARDS 2023 Global definition

Acceptable method of birth control

Exclusion Criteria

I have active Hepatitis B, untreated Hepatitis C, or a positive HIV test.

I regularly use medication that weakens my immune system.

My liver is not working well.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive GEn-1124 or placebo via IV infusion BID for 5 days

5 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Treatment Details

Interventions

• GEn-1124 (Other)
• Placebo (Other)

Trial Overview 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.

Participant Groups

Group I: Part 2: GEn-1124 Experimental Treatment 1 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-1124 Experimental Treatment 1 Intervention

Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days.

Group III: Part 1 Cohort 1: GEn-1124 Experimental Treatment 1 Intervention

Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days.

Group IV: Placebo Placebo Group 1 Intervention

Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).

Who Is Running the Clinical Trial?

GEn1E Lifesciences

Lead Sponsor

Trials

2

Recruited

100+