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NCT05574010 · ClinicalTrials.gov registry record · Phase 1
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
A Phase 1 study, sponsored by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion.
- Terminated
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
NCT05574010: Clinical Trial Phase 1 study, sponsored by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion.
NCT05574010 is a Phase 1 study that was terminated before completion, run by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion. The registered enrollment target is 128 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05574010, a Phase 1 study, was terminated before completion, sponsored by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
Study Summary
This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disabi
Interventions
- DRUG Cohort 1 in Part A
- DRUG Cohort 2 in Part A
- OTHER Placebo: Group 1 in Part B and Part C
- DRUG Group 2 in Part B and Part C
- DRUG Group 3 in Part B and Part C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2025-05-19 |
| Phase | Phase 1 |
Why NCT05574010 stopped before completion
NCT05574010 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher).
The record links to 0 conditions, and to 5 interventions - of which Cohort 1 in Part A is the first listed.
NCT05574010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05574010 about?
NCT05574010 is a clinical study titled "A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)". This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).
What is the current status of trial NCT05574010?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2022-11-15. Estimated completion is 2025-05-19.
What interventions are being tested in trial NCT05574010?
The interventions under investigation include: Cohort 1 in Part A (DRUG), Cohort 2 in Part A (DRUG), Placebo: Group 1 in Part B and Part C (OTHER), Group 2 in Part B and Part C (DRUG), Group 3 in Part B and Part C (DRUG).
Who is sponsoring clinical trial NCT05574010?
This trial is sponsored by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05574010's enrollment target sits among peer trials
128 452nd of 2000 higher than 1,542 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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