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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 9 through 60
Awards & highlights
Study Summary
This trial will test if GEn-1124 is safe & tolerable for treating ARDS, given in 2 doses within 48hrs & then twice daily for 5 days.
Who is the study for?
Adults aged 18-80 with a recent diagnosis of ARDS can join this trial. They must be hospitalized, able to consent, and use birth control. Excluded are burn victims with extensive injuries, those with unstable heart disease or severe lung conditions, people in prison or mental health facilities, anyone who's had organ transplants or certain infections like TB and hepatitis.Check my eligibility
What is being tested?
The study tests GEn-1124 against a placebo in patients with ARDS. Participants receive an IV infusion within 48 hours of diagnosis followed by twice-daily doses for five days to assess safety and tolerability.See study design
What are the potential side effects?
While the specific side effects of GEn-1124 aren't listed here, common side effects from similar treatments may include reactions at the infusion site, fatigue, potential allergic responses, and gastrointestinal discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 9 through 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 9 through 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124
Other outcome measures
Area under the plasma concentration versus time curve (AUC) for GEn-1124 and its metabolites.
Change in Euro Quality of Life Health Survey (EQ-5D-5L).
Change in Sequential Organ Failure Assessment (SOFA) score.
+26 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: GEn-1124Experimental Treatment1 Intervention
Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days.
Group II: Part 1 Cohort 2: GEn-1124Experimental Treatment1 Intervention
Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days.
Group III: Part 1 Cohort 1: GEn-1124Experimental Treatment1 Intervention
Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days.
Group IV: PlaceboPlacebo Group1 Intervention
Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).
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Who is running the clinical trial?
GEn1E LifesciencesLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Ritu Lal, PhD, MSStudy DirectorGEn1E Lifesciences
1 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active Hepatitis B, untreated Hepatitis C, or a positive HIV test.I regularly use medication that weakens my immune system.My liver is not working well.I haven't used any experimental drugs or devices recently.I am not solely on supportive care for my condition.I have a history of TB or am being treated for latent TB.I have had an organ or cell transplant.I am being treated for burns on more than 20% of my body or for smoke inhalation.My heart condition is stable.My condition is severe pulmonary hypertension.I have kidney disease.I have severe lung disease and need oxygen or have high CO2 levels.I am between 18 and 80 years old.I am currently admitted to a hospital.I have not been treated for cancer other than non-melanoma skin cancer in the last 6 months.I have had a severe injury that caused a lot of blood loss or might need major surgery soon.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Cohort 1: GEn-1124
- Group 2: Part 1 Cohort 2: GEn-1124
- Group 3: Placebo
- Group 4: Part 2: GEn-1124
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age limit for this clinical trial extend beyond 70 years of age?
"The minimum and maximum ages for enrollment into this clinical trial are 18 and 80 respectively, in accordance with the inclusion criteria."
Answered by AI
Can I qualify for the research trial?
"The terms of inclusion for this research endeavour necessitate that participants are suffering from acute respiratory distress syndrome and between 18-80 years old. As such, the investigators hope to enrol 52 people in total into their trial."
Answered by AI
Are there any openings for prospective patients to join this research?
"Clinicaltrials.gov confirms that this medical trial, which was first introduced on March 1st 2023 is not actively recruiting patients. However, there are currently 1571 other clinical trials open to participants nationwide."
Answered by AI
Are there any potential risks associated with the use of GEn-1124 in Part 1 Cohort 1?
"The safety of Part 1 Cohort 1: GEn-1124 is rated 2, as there are existing records of its efficacy but not yet any data confirming its safety."
Answered by AI
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