Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
A legfontosabb adatok
- Hol
- Anderson, Anniston, Columbus, Dayton, Denver, Great Neck, Jacksonville, Knoxville, Leesburg, Marrero, Meridian, Morehead City, New York, Ogden, Raleigh, Rochester, Waco és Winter Park (Egyesült Államok)Mind a 18 helyszín megnézése
- Fázis
- 1. fázis
Helyszínek itt: Egyesült Államok
- Velocity Clinical Research, AndersonAnderson, Egyesült ÁllamokNo longer taking part
- Pinnacle Research GroupAnniston, Egyesült ÁllamokNo longer taking part
- Aventiv Research IncColumbus, Egyesült ÁllamokNo longer taking part
- Digestive Specialists IncDayton, Egyesült ÁllamokNo longer taking part
- Mountain View Clinical ResearchDenver, Egyesült ÁllamokNo longer taking part
- Long Island Gastrointestinal Research GroupGreat Neck, Egyesült ÁllamokNo longer taking part
- Jacksonville Center for Clinical ResearchJacksonville, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty ResearchKnoxville, Egyesült ÁllamokNo longer taking part
- Clinical Site PartnersLeesburg, Egyesült ÁllamokNo longer taking part
- Tandem Clinical ResearchMarrero, Egyesült ÁllamokNo longer taking part
- Velocity Clinical Research, BoiseMeridian, Egyesült ÁllamokNo longer taking part
- Lucas Research - Diabetes & Endocrinology Consultants, PCMorehead City, Egyesült ÁllamokNo longer taking part
- Columbia University Medical CenterNew York, Egyesült ÁllamokNo longer taking part
- Care Access ResearchOgden, Egyesült ÁllamokNo longer taking part
- North Carolina Clinical ResearchRaleigh, Egyesült ÁllamokNo longer taking part
- Mayo Clinic - RochesterRochester, Egyesült ÁllamokNo longer taking part
- Digestive Research of Central TexasWaco, Egyesült ÁllamokNo longer taking part
- Clinical Site Partners - OrlandoWinter Park, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Chugai Pharmaceutical
- Azonosító
- NCT05425446
- A regiszteradat frissítve
- 2025. január 31.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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)
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.
Bevonási feltételek: History of medically diagnosed celiac disease based on biopsies and positive celiac serology; Be on a GFD for at least 12 months; HLA-DQ2.5 genotype; Experienced at most mild symptoms of celiac disease.
Kizáró feltételek: Refractory celiac disease; Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG).