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A Study to Investigate Safety and Tolerability of NDX-3315 in Healthy Participants and Patients With Eosinophilic Esophagitis

Study Purpose

An open-label phase 1b study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 in healthy participants and patients with eosinophilic esophagitis (EoE).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Healthy Participants: • Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) assessment.
  • - 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.

Exclusion Criteria:

  • - Medical Conditions: - Participant with presence of any other disease of the GI tract, including cancer, autoimmune esophageal disease, 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, if considered by the investigator a concern for the endoscopic procedure.
  • - History of recurrent aspiration pneumonia.
  • - History of bleeding disorders, liver cirrhosis or esophageal varices.
  • - A current malignancy or previous history of cancer in remission for less than 5 years prior to Screening (participants will not be excluded if they had localized carcinoma of the skin that was resected for cure).
  • - 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.
  • - Prior/Concomitant Therapy: - Participant who is on anticoagulation therapy that, in the investigator or Medical Monitor's opinion, cannot safely come off medication.
  • - Use of chronic aspirin, nonsteroidal agents, or anti-coagulants within 2 weeks prior to screening.
  • - Use of systemic corticosteroids within 3 months or swallowed topical corticosteroids within 6 weeks prior to Screening visit.
  • - Participant is being treated with systemic immunosuppression, carafate (sucralfate), or investigational agent of any kind within less than 3 months or 5 half-lives, whichever is longer, prior to Screening visit (this also includes investigational formulations of marketed products).
  • - Diagnostic Assessments: - Evidence of clinically significant abnormality in the hematological and biochemical assessments at Screening Visit, specifically: International Normalized Ratio (INR) >1.4; platelet count <80,000/μL and creatinine level >2 mg/dL.
  • - ECG: QTcF ≥450 msec for males and QTcF ≥470 msec for females at the time of screening.
  • - 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).
  • - Healthy Participants Only: A history or current diagnosis of allergic diseases (e.g., allergic rhinitis/sinusitis, asthma, atopic dermatitis, food allergies) or serum immunoglobulin E (IgE) level ≥100 kU/L.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NexEos Diagnostics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Additional Details

This study is a multi-site, Phase 1b, open-label study of orally administered NDX-3315 and esophageal imaging in healthy participants and participants with EoE. Study details include:

  • - The study duration or period will be up to around 10 weeks.
  • - Participants will receive either one or two doses of NDX-3315 depending on their assigned regimen arm.
EoE participants will receive two doses; healthy participants will receive one dose.
  • - The visit frequency will be three site visits for healthy participants and four site visits for EoE participants followed by one follow-up phone call visit within the study period.

Arms & Interventions


Experimental: Regimen 5

NDX-3315 delivered via oral syringe at ~ 3 mL per minute .

Experimental: Regimen 10

NDX-3315 delivered via oral syringe at ~ 1.5 mL per minute.

Experimental: Regimen 1

NDX-3315 delivered via oral syringe single ~15 mL dose.

Experimental: Regimen 10 (Supine)

NDX-3315 delivered via oral syringe at ~ 1.5 mL per minute while in supine position.


Drug: - NDX-3315

Oral solution

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pennsylvania, Philadelphia, Pennsylvania




University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Research Manager


(484) 267-3909

University of Utah, Salt Lake City, Utah




University of Utah

Salt Lake City, Utah, 84132

Site Contact

Research Manager


(484) 267-3909

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