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

Evaluating KAN-101's effects and safety in celiac patients.

Recruiting
18-70 years
All
Phase 1/2

This study tests the safety and effects of a new drug called KAN-101 for people with Celiac Disease, a condition where eating gluten causes harm to the small intestine. The study is in three parts and includes up to 132 adult participants. Part A tests different amounts of KAN-101 to see how safe it is. Parts B and C compare KAN-101 with a placebo (a pill with no medicine) to see how the body responds. Participants must be on a gluten-free diet and will face a gluten challenge test to check the body's reaction. The study lasts about 56 days, with 28 days for checking if you can join, 7 days of taking the drug, and 21 days of follow-up.

  • Duration: 56 days total, including screening, treatment, and follow-up.
  • Eligibility: Adults with Celiac Disease on a gluten-free diet.
  • Risks: Gluten challenge test may cause symptoms.

You can participate if you have Celiac Disease, follow a gluten-free diet for at least a year, and meet certain genetic and health conditions. You cannot join if you have other illnesses like diabetes or have had a gluten challenge recently. Always discuss with your doctor before joining a study.

Study details
    Celiac Disease

NCT05574010

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

10 October 2024

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