NCT04248855

Assessment of KAN-101 in Celiac Disease (ACeD)

A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A safety study of KAN-101 in patients with celiac disease. The study has two parts: 1. Part A - first in human study in which patients receive a single dose of KAN-101 2. Part B - patients will receive three doses of either KAN-101 or placebo

Detailed description

Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD). An overview of the two parts and proposed dose groups is given below: 1. Part A (SAD): Patients will receive a single dose of KAN-101. 2. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	KAN-101	Intravenous (IV) infusion
DRUG	Placebo	Intravenous (IV) infusion

Timeline

• Start date: 2020-01-21
• Primary completion: 2021-10-08
• Completion: 2021-10-08
• First posted: 2020-01-30
• Last updated: 2024-08-06
• Results posted: 2024-03-21

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study