A Study to Investigate Safety and Tolerability of NDX-3315 and NDX-3324 in Healthy Participants and Patients With Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title: An Open-label Phase 1b Study Assessing the Safety, Tolerability and Preliminary Diagnostic Performance of a Radioactive Imaging Agent, NDX-3315 and NDX-3324, in Healthy Adult Participants and Patients With Eosinophilic Esophagitis

Status Recruiting

Clinical Trial Summary

An open-label phase 1b 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).

Clinical Trial Description

This study is a multi-site, Phase 1b, open-label study of orally administered NDX-3315 or NDX-3324 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 or NDX-3324 depending on their assigned regimen arm. EoE participants will receive two doses; healthy participants will receive one dose. There will be a SPECT/CT scan performed at each 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. ;

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

• NCT number: NCT05757856
• Study type: Interventional
• Source: NexEos Diagnostics, Inc.
• Contact: NDX-3315-1001 Study Team
• Phone: (484) 267-3909
• Email: clinicaltrials.gov@nexeosdx.com
• Status: Recruiting
• Phase: Phase 1
• Start date: January 20, 2023
• Completion date: September 2024