Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05425446 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
A Phase 1 study, sponsored by Chugai Pharmaceutical.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT05425446: Completed Phase 1 study, sponsored by Chugai Pharmaceutical.
NCT05425446 is a Phase 1 study that has completed, run by Chugai Pharmaceutical. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05425446, a Phase 1 study, has completed, sponsored by Chugai Pharmaceutical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.
Primary Outcome
Incidence and severity of TEAEs and its relationship to the study drugs
Interventions
- DRUG Placebo
- DRUG DONQ52
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2025-01-17 |
| Phase | Phase 1 |
What the finished NCT05425446 record still lists
NCT05425446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05425446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05425446 about?
NCT05425446 is a clinical study titled "Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients". This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.
What is the current status of trial NCT05425446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2022-09-19. Estimated completion is 2025-01-17.
What interventions are being tested in trial NCT05425446?
The interventions under investigation include: Placebo (DRUG), DONQ52 (DRUG).
Who is sponsoring clinical trial NCT05425446?
This trial is sponsored by Chugai Pharmaceutical, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05425446's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02287428 · 56 participants · Phase 1
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
- NCT02923011 · 56 participants · Phase 3
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
- NCT02935283 · 56 participants
Neuroimaging and Neuropsychological Outcomes in Urea Cycle Disorders
- NCT03375866 · 56 participants · NA
Effects of Mixed Nut Consumption on Satiety and Weight Management
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI