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

ID#: NCT05795465

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: April 04, 2023

End Date: July 01, 2024

Contact Information:
Ritu Lal, PhD, MS
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.

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

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. 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 6 months.

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

6. Moderate to severe liver failure.

7. Acute or chronic kidney disease.

8. Unstable cardiac disease.

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

10. 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.

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

12. Chronic use of immunosuppressants, including corticosteroids.

13. Moribund subject not expected to survive 24 hours.

14. Do not resuscitate (DNR) status.

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

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

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

18. 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).

19. Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.

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

21. 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.