A Phase 2, Two-Part Study to Evaluate the Safety and Tolerability of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
United States
Washington, D.c.
Medstar Washington Hospital Center
WITHDRAWN
Washington D.c.
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
University of Maryland - Baltimore Washington Medical Center
RECRUITING
Glen Burnie
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Mississippi
Ocean Springs Hospital
COMPLETED
Ocean Springs
New Jersey
Cooper University Hospital
RECRUITING
Camden
New York
The Mount Sinai Hospital
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Texas
Houston Methodist Hospital
WITHDRAWN
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
Contact Information
Primary
Ritu Lal, PhD, MS
clinical@gen1elifesci.com
(650) 248-2429
Time Frame
Start Date: 2023-04-04
Estimated Completion Date: 2026-12
Participants
Target number of participants: 52
Treatments
Experimental: Part 1 Cohort 1: GEn-1124
Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days.
Experimental: Part 1 Cohort 2: GEn-1124
Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days.
Placebo_comparator: Placebo
Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).
Experimental: Part 2: GEn-1124
Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days.
Related Therapeutic Areas
Sponsors
Leads: GEn1E Lifesciences