Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT05757856
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2023-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate Safety and Tolerability of NDX-3315 and NDX-3324 in Healthy Participants and Patients With Eosinophilic Esophagitis
Sponsor:
NexEos Diagnostics, Inc.
Organization:
Study Overview
Official Title:
An Open-label Phase 2 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:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
This study is a multi-site, Phase 2, 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: