Clinical Trial: A Study to Investigate Safety and Tolerability of NDX-3315 in Healthy Participants and Patients With Eosinophilic Esophagitis
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: An Open-label Phase 1b Study Assessing the Safety, Tolerability and Preliminary Diagnostic Performance of a Radioactive Imaging Agent, NDX-3315, in Healthy Adult Participants and Patients With Eosinop
Brief Summary: 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).
Detailed Summary:
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.
Sponsor: NexEos Diagnostics, Inc.
Current Primary Outcome: An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product and that does not necessarily have causal relationship with this treatment.
Original Primary Outcome: An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product and that does not necessarily have causal relationship with this treatment.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: NexEos Diagnostics, Inc.
Dates:
Date Received: February 10, 2023
Date Started: January 20, 2023
Date Completion: January 20, 2023
Last Updated: May 04, 2023
Last Verified: May 01, 2023
