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A Study of GEn-1124 in Subjects with Acute Respiratory Distress Syndrome (ARDS)

Sponsored by GEn1E Lifesciences

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Oct 22, 2025

Phase

Clinical Trial

Sponsor

GEn1E Lifesciences

Enrollment Target

52

Start Date

Apr 2023

๐Ÿ“Š
1 of 52 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Male or female subject between the ages of 18 and 80 years old, inclusive. 2. Written informed consent . 3. Dosing as early as possible after first meeting ARDS 2023 Global definition. 4. Acceptable method of birth control.

Exclusion Criteria

Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures. 2. Pregnant or breastfeeding 3. Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility. 4. Active malignancy (other than non-melanoma skin cancer) requiring treatment within the last 3 months or within the last 6 months if an anti-B cell antibody was received. 5. Any other irreversible disease or condition for which 6-month mortality is estimated to be \>50%. 6. Moderate to severe liver failure. 7. Estimated glomerular filtration rate (eGFR) \<10 mL/min/1.73 m2 or requiring dialysis at screening. 8. Acute Left ventricular failure or congestive heart fail

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

52 participants

๐ŸŽ‚

Age Range

18 Years - 80 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

GEn1E Lifesciences

Study Locations

Choose your preferred location or select flexible during enrollment

WITHDRAWN

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
RECRUITING

Kansas City

Kansas

Location available
View Kansas City location page
RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page
RECRUITING

Glen Burnie

Maryland

Location available
View Glen Burnie location page
COMPLETED

Ocean Springs

Mississippi

Location available
View Ocean Springs location page
RECRUITING

St Louis

Missouri

Location available
View St Louis location page
RECRUITING

Camden

New Jersey

Location available
View Camden location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Cleveland

Ohio

Location available
View Cleveland location page

๐Ÿ“ And 2 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Looking for Acute Respiratory Distress Syndrome Treatment in Washington D.C.?

Join others in District of Columbia exploring innovative treatment options through clinical research

Acute Respiratory Distress Syndrome Treatment Options in Washington D.C., District of Columbia

If you're searching for Acute Respiratory Distress Syndrome treatment in Washington D.C., participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Washington D.C., Kansas City, Ocean Springs and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Acute Respiratory Distress Syndrome. All study-related care is provided at no cost to participants.

Local Sites
3 locations in District of Columbia
Now Enrolling
Up to 52 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Acute Respiratory Distress Syndrome?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Acute Respiratory Distress Syndrome

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Acute Respiratory Distress Syndrome Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05795465. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.