Assessment of KAN-101 in Celiac Disease (ACeD)

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

Detailed Description
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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.

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

Conditions
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Celiac Disease

Intervention / Treatment
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* Drug: KAN-101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Adults aged 18 to 70 years inclusive Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes) Has followed a GFD for > 12 months immediately prior to study entry Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods Capable of understanding and complying with protocol requirements Patient understands and has signed the informed consent form Key Exclusion Criteria: Refractory celiac disease Selective IgA deficiency Positive for HLA-DQ8 (DQA1*03, DQB1*0302) Previous treatment with tolerance-inducing therapies for celiac disease Known wheat allergy Part B only: History of hyperacute or prolonged symptoms following gluten exposure Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation History of dermatitis herpetiformis Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAD Cohort 1<br>All enrolled patients will receive one dose of KAN-101 Dose A | Drug: KAN-101<br>* Intravenous (IV) infusion<br>|
| Experimental: SAD Cohort 2<br>All enrolled patients will receive one dose of KAN-101 Dose B | Drug: KAN-101<br>* Intravenous (IV) infusion<br>|
| Experimental: SAD Cohort 3<br>All enrolled patients will receive one dose of KAN-101 Dose C | Drug: KAN-101<br>* Intravenous (IV) infusion<br>|
| Experimental: SAD Cohort 4<br>All enrolled patients will receive one dose of KAN-101 Dose D | Drug: KAN-101<br>* Intravenous (IV) infusion<br>|
| Experimental: MAD Cohort 5<br>All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo | Drug: KAN-101<br>* Intravenous (IV) infusion<br>Drug: Placebo<br>* Intravenous (IV) infusion<br>|
| Experimental: MAD Cohort 6<br>All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo | Drug: KAN-101<br>* Intravenous (IV) infusion<br>Drug: Placebo<br>* Intravenous (IV) infusion<br>|
| Experimental: MAD Cohort 7<br>All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo | Drug: KAN-101<br>* Intravenous (IV) infusion<br>Drug: Placebo<br>* Intravenous (IV) infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher |  | Up to 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean of maximum plasma concentration (Cmax) |  | Up to 15 days | 
| Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last) |  | Up to 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Double blind, Multicenter