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A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

NCT05574010

TerminatedPhase 1, Phase 2

Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Conditions: Celiac Disease

Interventions: Cohort 1 in Part A, Cohort 2 in Part A, Placebo: Group 1 in Part B and Part C, Group 2 in Part B and Part C, Group 3 in Part B and Part C

Countries: United States, Australia, New Zealand

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* Refractory celiac disease
* HLA-DQ8 genotype
* Previous oral gluten challenge within 12 months
* Selective IgA deficiency
* Diagnosis of Type-1 diabetes
* Active gastrointestinal diseases
* History of dermatitis herpetiformis
Locations (36)
  • Birmingham, Alabama, United States
  • Anaheim, California, United States
  • St. Petersburg, Florida, United States
  • Sandy Springs, Georgia, United States
  • Chicago, Illinois, United States
  • Normal, Illinois, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Rochester, Minnesota, United States
  • Saint Paul, Minnesota, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • Raleigh, North Carolina, United States
  • Columbus, Ohio, United States
  • Mentor, Ohio, United States
  • Westlake, Ohio, United States
  • Hershey, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Waco, Texas, United States
  • Ogden, Utah, United States
  • West Jordan, Utah, United States
  • Campbelltown, New South Wales, Australia
  • Auchenflower, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Box Hill, Victoria, Australia
  • Parkville, Victoria, Australia
  • Midland, Western Australia, Australia
  • Auckland, Auckland, New Zealand
  • + 6 more on CT.gov