Study on KAN-101 for Celiac Disease: This study looks at how the drug KAN-101 works in people with Celiac Disease (CeD), which is a condition where eating gluten (a protein found in wheat, barley, and rye) can damage the small intestine. The study aims to understand the drug's safety, how well people can handle it, and how it affects the body (pharmacodynamics and pharmacokinetics).
The study has three parts:
- Part A: Open-label (everyone knows what treatment is given), lasts about 56 days with screening, treatment, and follow-up.
- Parts B and C: Double-blind (neither participants nor researchers know who is getting the drug or placebo), involves a gluten challenge, and tests different doses.
Key Points:
- The study includes a gluten challenge, which means participants will eat gluten to test the drug's effects.
- Participants must follow a gluten-free diet for at least 12 months before joining.
- Eligibility excludes those with certain health conditions and those who had a gluten challenge in the past year.
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