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

NCT05795465 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GEn-1124-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Respiratory Distress Syndrome, Acute

Outcome Measures

Primary Outcomes (1)

• 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).

  Through study completion, Day 60

Other Outcomes (29)

• Change in oxygenation index (OI).

  Through study completion, Day 60

• Change in ratio of arterial oxygen partial pressure to fractional inspired oxygen.

  Through study completion, Day 60

• Change in static compliance.

  Through study completion, Day 60

Study Arms (4)

Part 1 Cohort 1: GEn-1124

EXPERIMENTAL

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

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.

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).

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.

Drug: GEn-1124

Interventions

GEn-1124 DRUG

Intravenous infusion

Part 1 Cohort 1: GEn-1124; Part 1 Cohort 2: GEn-1124; Part 2: GEn-1124

Placebo DRUG

Intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GEn1E Lifesciences: lead

Study Sites (11)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

WITHDRAWN

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

University of Maryland - Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

RECRUITING

Ocean Springs Hospital

Ocean Springs, Mississippi, 39564, United States

COMPLETED

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

The Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

WITHDRAWN

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Related Links

• GEn1E Lifesciences

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ritu Lal, PhD, MS

  GEn1E Lifesciences

  STUDY DIRECTOR

Central Study Contacts

Ritu Lal, PhD, MS

CONTACT

(650) 248-2429; clinical@gen1elifesci.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All subjects, investigators, and study personnel involved in the conduct of the study, including data management, will be blinded to treatment assignment with the exception of some designated personnel. The unblinded study personnel will not participate in study procedures or data analysis prior to unblinding of the study data to all study-related personnel.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 - Randomized, double-blind, dose escalation. Part 2 - Randomized, double-blind, placebo controlled, parallel group.

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: April 3, 2023
• Study Start: April 4, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (11)