NDX-3315 + NDX-3324 for Eosinophilic Esophagitis

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: NexEos Diagnostics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?An open-label phase 2 study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 and NDX-3324 in healthy participants and patients with eosinophilic esophagitis (EoE).

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with EoE and often have trouble swallowing solid foods.

I am healthy based on medical exams, lab tests, and heart checks.

Exclusion Criteria

Medical Conditions: Participant with presence of any other disease of the GI tract, including cancer, autoimmune esophageal disease, symptomatic or uncontrolled GERD, Barrett's esophagus, eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatory bowel disease, or celiac disease. Known motility disorder of esophagus; achalasia or suspicion thereof. Sleep apnea considered a concern for the endoscopic procedure. History of recurrent aspiration pneumonia. History of bleeding disorders, liver cirrhosis or esophageal varices. Current malignancy or previous history of cancer in remission for less than 5 years prior to Screening. Participant with a Body Mass Index >40 m2/kg or inability to undergo a CT (or SPECT scan) due to weight limitations. Participant is pregnant or nursing.

My blood tests show abnormal INR, platelet count, and creatinine levels. My ECG results are also outside the normal range.

Other Exclusion Criteria: Any condition that would not permit adequate biopsies of the esophagus (e.g., esophageal varices, significant stricture precluding passage of a 9 mm endoscope, known allergy to sedative used for endoscopy). Healthy Participants Only: A history or current diagnosis of allergic diseases (Should be discussed with Medical Monitor and PI to decide whether exclusionary), autoimmune disease, chronic rhinosinusitis or serum immunoglobulin E (IgE) level ≥100 kU/L. On any medications including NSAIDS and any over the counter (OTC) medications unless it is birth control or acne medications with the exception of Accutane, or if deemed acceptable to use by Medical Monitor and PI.

+1 more

Participant Groups

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.

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.