Respiratory Distress Syndrome, AcutePhase 2NCT05795465
A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 study testing GEn-1124 in people with Respiratory Distress Syndrome, Acute, run by GEn1E Lifesciences at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Distress Syndrome, Acute
- What is being tested?
- GEn-1124
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Apr 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject between the ages of 18 and 85 years old, inclusive.
- Written informed consent .
- Dosing as early as possible after first meeting ARDS 2023 Global definition.
- Acceptable method of birth control.
Who cannot join
- Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.
- Pregnant or breastfeeding
- Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.
- Active malignancy (other than non-melanoma skin cancer) requiring treatment with immunosuppressant drugs within the last 3 months or within the last 6 months if an anti-B cell antibody was received.
- Any other irreversible disease or condition for which 6-month mortality is estimated to be >50%.
- Moderate to severe liver failure.
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- Estimated glomerular filtration rate (eGFR) <10 mL/min/1.73 m2 or requiring dialysis at screening.
- Subjects with known:
- New York Heart Association Class IV heart disease; or
- Acute Coronary Syndrome within the past 30 days (e.g., myocardial infarction, unstable angina) or dosing; or
- Cardiac arrest within 30 days of dosing with sequelae likely to increase mortality.
- Severe chronic respiratory disease with continuous home oxygen >2 liters per minute (LPM) or >28% (adjusted for altitude); and/or home noninvasive ventilation (except for the treatment of obstructive sleep apnea).
- Poly-traumatic injury resulting in significant blood loss and/or likely to require major surgery within the study period, or subject condition that would interfere with study procedures.
- History of any type of solid organ or cellular transplant.
- Receiving immunosuppressive therapy for solid organ or hematopoietic cancer, transplant anti-rejection medication, and/or other chronic conditions.
- Moribund subject not expected to survive 24 hours.
- Do not resuscitate (DNR) status.
- World Health Organization (WHO) functional class III or IV pulmonary hypertension.
- Subject has been on mechanical ventilation for more than 7 days at time of dosing.
- Burn victims currently undergoing treatment for >40% total body surface area (TBSA) involvement or for known airway inhalation injury.
- Neuromuscular disease that could impact ability to wean from mechanical ventilation.
- History of tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of Screening of a positive TB test).
- Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.
- Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.
- Any other medical, psychiatric, or social condition that, in the opinion of the investigator, is likely to unfavorably alter the risk-benefit of subject participation, to interfere with protocol compliance, or to confound safety.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 5 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
University of Maryland - Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
- Withdrawn
Houston Methodist Hospital
Houston, Texas, 77030
- Withdrawn
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
- Withdrawn
The Mount Sinai Hospital
New York, New York, 10029
- Completed
Ocean Springs Hospital
Ocean Springs, Mississippi, 39564
- Withdrawn
Washington University School of Medicine
St Louis, Missouri, 63110
- Withdrawn
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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)
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.
Read the detailed description
Randomized , double-blind, placebo controlled, dose escalation study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GEn1124.
GEn-1124 or placebo will be administered as a 2-hour IV infusion as early as possible after ARDS diagnosis. Participants will receive a second dose approximately 8 hours after the first and will continue BID for the remaining schedule (Days 2-5). Follow-up will be for a total of 60 days after the first dose or death (whichever comes first).
An independent Safety Review Committee (SRC) will be responsible for reviewing data throughout the study.
- Conditions
- Respiratory Distress Syndrome, Acute
- Being tested
- GEn-1124, Placebo
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEn-1124Drug
Intravenous infusion
PlaceboDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1: GEn-1124 | Experimental | Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days. Receives: Drug: GEn-1124 |
| Part 1 Cohort 2: GEn-1124 | Experimental | Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days. Receives: Drug: GEn-1124 |
| Placebo | Placebo comparator | Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days). Receives: Drug: Placebo |
| Part 2: GEn-1124 | Experimental | Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days. Receives: Drug: GEn-1124 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124
- Incidence (frequency over time) of serious adverse events (SAEs) unexpected in ARDS patients.
- Incidence (frequency over time) of treatment-emergent adverse events (TEAE).
Measured: Through study completion, Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start4 Apr 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 - Randomized, double-blind, dose escalation. Part 2 - Randomized, double-blind, placebo controlled, parallel group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GEn1E Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ritu Lal, PhD, MS, Study director, GEn1E Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795465
- Sponsor's protocol ID
- GEn-1124-002
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05795465
- Acronym / sponsor ID
- GEn-1124-002
- Conditions
- Respiratory Distress Syndrome, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- GEn1E LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized , double-blind, placebo controlled, dose escalation study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GEn1124.
GEn-1124 or placebo will be administered as a 2-hour IV infusion as early as possible after ARDS diagnosis. Participants will receive a second dose approximately 8 hours after the first and will continue BID for the remaining schedule (Days 2-5). Follow-up will be for a total of 60 days after the first dose or death (whichever comes first).
An independent Safety Review Committee (SRC) will be responsible for reviewing data throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Part 1 - Randomized, double-blind, dose escalation. Part 2 - Randomized, double-blind, placebo controlled, parallel group.
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1: GEn-1124 | Experimental | Drug: GEn-1124Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days. |
| Part 1 Cohort 2: GEn-1124 | Experimental | Drug: GEn-1124Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days). |
| Part 2: GEn-1124 | Experimental | Drug: GEn-1124Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subject between the ages of 18 and 85 years old, inclusive.
- Written informed consent .
- Dosing as early as possible after first meeting ARDS 2023 Global definition.
- Acceptable method of birth control.
Key exclusion criteria (25 listed)
- Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.
- Pregnant or breastfeeding
- Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.
- Active malignancy (other than non-melanoma skin cancer) requiring treatment with immunosuppressant drugs within the last 3 months or within the last 6 months if an anti-B cell antibody was received.
- Any other irreversible disease or condition for which 6-month mortality is estimated to be >50%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEn-1124Intravenous infusion | Drug | Part 1 Cohort 1: GEn-1124, Part 1 Cohort 2: GEn-1124, Part 2: GEn-1124 |
| PlaceboIntravenous infusion | Drug | Placebo |
Primary outcome
To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124
Time frame: Through study completion, Day 60
* Incidence (frequency over time) of serious adverse events (SAEs) unexpected in ARDS patients. * Incidence (frequency over time) of treatment-emergent adverse events (TEAE).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- GEn1E LifesciencesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ritu Lal, PhD, MS study director
GEn1E Lifesciences
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GEn-1124 in people with Respiratory Distress Syndrome, Acute, run by GEn1E Lifesciences at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ritu Lal, PhD, MS ((650) 248-2429, clinical@gen1elifesci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124 (time frame: Through study completion, Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.