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Radiopharmaceutical Agent

NDX-3315 + NDX-3324 for Eosinophilic Esophagitis

Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 hours post-dose (up to 1 week)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute quantification of SPECT imaging
Determine Concordance of Outcomes
Peak eosinophil counts per high-power field (HPF)
+1 more
Secondary study objectives
Deposition of eMBP1
EoE Endoscopic Reference Score (EREFS)
EoE Symptom Collection Questionnaire
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Regimen 10 (Reclined)Experimental Treatment1 Intervention
NDX-3315 or NDX-3324 delivered via oral syringe at \~ 1.5 mL per minute while sitting reclined.

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Who is running the clinical trial?

NexEos Diagnostics, Inc.Lead Sponsor
~13 spots leftby Nov 2025
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