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Radiopharmaceutical Agent

Regimen 5 for Eosinophilic Esophagitis

Phase 1
Recruiting
Research Sponsored by NexEos Diagnostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
EoE Participants: Documented diagnosis of EoE (based on prior endoscopy with biopsies showing eosinophils ≥15 / HPF) and history (by patient report) of recurrent dysphagia and/or other related EoE symptoms (with intake of solids off anti-inflammatory therapy) prior to screening; dysphagia is defined as trouble swallowing solid food, or having solid food stuck, by patient report.
Healthy Participants: Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) assessment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 hours post-dose (up to 1 week)
Awards & highlights

Study Summary

This trial tests a new drug to see if it is safe & effective at treating EoE in healthy people & patients with the condition.

Who is the study for?
This trial is for healthy individuals and those with Eosinophilic Esophagitis (EoE), characterized by difficulty swallowing or food getting stuck. Participants must have a documented diagnosis of EoE, be in good health as confirmed by medical exams, and not have certain conditions like sleep apnea that could complicate procedures. They can't join if they've had cancer in the last 5 years (except certain skin cancers), are very overweight, pregnant/nursing, on specific medications recently, or have other GI diseases.Check my eligibility
What is being tested?
The study is testing two oral radiopharmaceutical agents called NDX-3315 and NDX-3324 to see how safe they are and how well they work as diagnostic tools for EoE. It's an early-phase trial where both healthy participants and those with EoE will take the drugs so researchers can compare results.See study design
What are the potential side effects?
Since this is an early safety study of NDX-3315 and NDX-3324, potential side effects aren't fully known yet. However, typical risks may include allergic reactions to the compounds or discomfort from procedures related to the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with EoE and often have trouble swallowing solid foods.
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I am healthy based on medical exams, lab tests, and heart checks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 hours post-dose (up to 1 week)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 hours post-dose (up to 1 week) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of all participants with AEs following administration of NDX-3315 and NDX-3324
Secondary outcome measures
Absolute quantification of SPECT imaging
Deposition of eMBP1
EoE Endoscopic Reference Score (EREFS)
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Regimen 5Experimental Treatment1 Intervention
NDX-3315 or NDX-3324 delivered via oral syringe at ~ 3 mL per minute .
Group II: Regimen 10 (Reclined)Experimental Treatment1 Intervention
NDX-3315 or NDX-3324 delivered via oral syringe at ~ 1.5 mL per minute while sitting reclined.
Group III: Regimen 10Experimental Treatment1 Intervention
NDX-3315 or NDX-3324 delivered via oral syringe at ~ 1.5 mL per minute.
Group IV: Regimen 1Experimental Treatment1 Intervention
NDX-3315 or NDX-3324 delivered via oral syringe single ~15 mL dose.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

NexEos Diagnostics, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 or older eligible for this research project?

"This research project is looking for volunteers aged between 18 and 65 years old."

Answered by AI

Has the U.S. Food & Drug Administration sanctioned Regimen 5?

"Our experts at Power assessed the safety of Regimen 5 as a 1, taking into account that this is an early phase trial with limited data available to support its efficacy and safety."

Answered by AI

What is the current enrollment for this clinical experimentation?

"Affirmative. The information available on clinicaltrials.gov alludes to this medical trial recruiting participants at the present moment. This particular experiment was initially published on January 20th, 2023 and has since been updated on February 23rd, 2023 with a goal of enrolling 24 patients from one facility."

Answered by AI

Does my profile meet the selection criteria for this research endeavor?

"Those who wish to be included in this medical study must have a diagnosis of eosinophilic esophagitis and fall within the age bracket of 18-65 years old. The trial is set to accept 24 participants."

Answered by AI

Is enrollment for this research study still open to participants?

"Affirmative. The details presented on clinicaltrials.gov suggest that recruitment for this research study is still underway, with 24 individuals required to be selected from a single site since the initial posting date of January 20th 2023 and most recent update occurring February 23rd 2023."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
University of Utah
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have suffered from eosinophilic esophagitis since I was 7. This has lead to many choking episodes requiring me to throw up or suffer with having a piece of food stuck in my throat for many days.
PatientReceived 2+ prior treatments
~9 spots leftby Sep 2024