A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
Megadott ok: Sponsor decision
A legfontosabb adatok
- Hol
- Anaheim, Birmingham, Chicago, Columbus, Hershey, Houston, Indianapolis, Iowa City, Mentor, Nashville, New York, Normal, Ogden, Omaha, Raleigh, Rochester, Saint Paul, Sandy Springs, St Louis, St. Petersburg, Waco, West Jordan és Westlake (Egyesült Államok)Mind a 23 helyszín megnézése
- Fázis
- 1/2. fázis
Helyszínek itt: Egyesült Államok
- Anaheim Clinical Trials, LLCAnaheim, Egyesült ÁllamokNo longer taking part
- University of Alabama at BirminghamBirmingham, Egyesült ÁllamokNo longer taking part
- Rush University Medical CenterChicago, Egyesült ÁllamokNo longer taking part
- Aventiv Research, Inc. d/b/a Centricity ResearchColumbus, Egyesült ÁllamokNo longer taking part
- Penn State Milton S. Hershey Medical CenterHershey, Egyesült ÁllamokNo longer taking part
- The University of Texas Health Science Center at HoustonHouston, Egyesült ÁllamokNo longer taking part
- Indiana University Health University HospitalIndianapolis, Egyesült ÁllamokNo longer taking part
- University of IowaIowa City, Egyesült ÁllamokNo longer taking part
- Great Lakes Gastroenterology Research, LLCMentor, Egyesült ÁllamokNo longer taking part
- Vanderbilt University Medical CenterNashville, Egyesült ÁllamokNo longer taking part
- Celiac Disease Center at Columbia UniversityNew York, Egyesült ÁllamokNo longer taking part
- Sneeze, Wheeze, & Itch Associates LLCNormal, Egyesült ÁllamokNo longer taking part
- Advanced Research InstituteOgden, Egyesült ÁllamokNo longer taking part
- Quality Clinical ResearchOmaha, Egyesült ÁllamokNo longer taking part
- North Carolina Clinical ResearchRaleigh, Egyesült ÁllamokNo longer taking part
- Mayo ClinicRochester, Egyesült ÁllamokNo longer taking part
- Prism Research LLC dba Nucleus NetworkSaint Paul, Egyesült ÁllamokNo longer taking part
- Agile Clinical Research TrialsSandy Springs, Egyesült ÁllamokNo longer taking part
- Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
- GCP ResearchSt. Petersburg, Egyesült ÁllamokNo longer taking part
- Digestive Research of Central TexasWaco, Egyesült ÁllamokNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, Egyesült ÁllamokNo longer taking part
- Northshore Gastroenterology Research, LLCWestlake, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
- Azonosító
- NCT05574010
- A regiszteradat frissítve
- 2026. március 10.
- Eredeti leírás
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).A teljes eredeti leírásKevesebb
A Phase 1B Open-label/Phase 2 Double-blind Placebo- Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients With Celiac Disease (CeD)
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).
Bevonási feltételek: Previous diagnosis of celiac disease based on histology and positive celiac serology; HLA-DQ2.5 genotype; Gluten-free diet for at least 12 months; Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening.
Kizáró feltételek: Previous oral gluten challenge within 12 months; Refractory celiac disease; Diagnosis of Type-1 diabetes; Active gastrointestinal diseases; History of dermatitis herpetiformis; HLA-DQ8 genotype; Selective IgA deficiency.