Assessment of KAN-101 in Celiac Disease (ACeD)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Celiac Disease
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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: Part A (SAD): Patients will receive a single dose of KAN-101. Part B...
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: Part A (SAD): Patients will receive a single dose of KAN-101. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.
Tracking Information
- NCT #
- NCT04248855
- Collaborators
- Not Provided
- Investigators
- Not Provided