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

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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 within 48 hours of 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GEn1E Lifesciences

Criteria

Inclusion Criteria:

1. Male or female subject between the ages of 18 and 80 years old, inclusive.

2. Written informed consent .

3. Hospital admission.

4. Dosing within 48 hours of first meeting ARDS.

5. Acceptable method of birth control.

Exclusion Criteria:

1. Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.

2. Pregnant or breastfeeding

3. Body mass index (BMI) <18 or >40 kg/m2.

4. Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.

5. Active malignancy (other than non-melanoma skin cancer) requiring treatment within the last one year.

6. Any other irreversible disease or condition for which 6-month mortality is estimated to be >50%.

7. Moderate to severe liver failure.

8. Acute or chronic kidney disease.

9. Unstable cardiac disease.

10. Severe chronic respiratory disease with a partial pressure of carbon dioxide (PaCO2) >50 mmHg or the use of home oxygen.

11. 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.

12. History of any type of solid organ or cellular transplant.

13. Chronic use of immunosuppressants, including corticosteroids.

14. Moribund subject not expected to survive 24 hours.

15. Do not resuscitate (DNR) status.

16. World Health Organization (WHO) functional class III or IV pulmonary hypertension.

17. Burn victims currently undergoing treatment for >20% total body surface area (TBSA) involvement or for known airway inhalation injury.

18. Neuromuscular disease that could impact ability to wean from mechanical ventilation.

19. 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).

20. Positive Hepatitis B (except due to recent Hepatitis B vaccination), Hepatitis C, or human immunodeficiency (HIV) screen.

21. Subjects on ongoing chronic use of corticosteroids at the time of randomization.

22. Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.

23. 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.