Trials / Completed
CompletedNCT05425446
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DONQ52 | Subcutaneous (SC) injection |
| DRUG | Placebo | Subcutaneous (SC) injection |
Timeline
- Start date
- 2022-09-19
- Primary completion
- 2024-08-09
- Completion
- 2025-01-17
- First posted
- 2022-06-21
- Last updated
- 2025-01-31
Locations
21 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05425446. Inclusion in this directory is not an endorsement.