Trial | NCT04248855  Report issue

Title

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)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    KAN-101 ...

  • Study Participants

    41
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
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.
Study Started
Jan 21
2020
Primary Completion
Oct 08
2021
Study Completion
Oct 08
2021
Last Update
Nov 22
2021

Drug KAN-101

Intravenous (IV) infusion

Drug Placebo

Intravenous (IV) infusion

SAD Cohort 1 Experimental

All enrolled patients will receive one dose of KAN-101 Dose A

SAD Cohort 2 Experimental

All enrolled patients will receive one dose of KAN-101 Dose B

SAD Cohort 3 Experimental

All enrolled patients will receive one dose of KAN-101 Dose C

SAD Cohort 4 Experimental

All enrolled patients will receive one dose of KAN-101 Dose D

MAD Cohort 5 Experimental

All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo

MAD Cohort 6 Experimental

All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo

MAD Cohort 7 Experimental

All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo

Criteria 

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
No Results Posted