A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

Purpose

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

Condition

  • Celiac Disease

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Previous diagnosis of celiac disease based on histology and positive celiac serology - HLA-DQ2.5 genotype - Gluten-free diet for at least 12 months - Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening

Exclusion Criteria

  • Refractory celiac disease - HLA-DQ8 genotype - Previous oral gluten challenge within 12 months - Selective IgA deficiency - Diagnosis of Type-1 diabetes - Active gastrointestinal diseases - History of dermatitis herpetiformis

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Part A: This part of the study is an open label with up to 6 participants in each dose cohort. There will be 2 dose cohorts. Part B and Part C: These parts of the study have a randomized, double- blinded, placebo-controlled, parallel study design.
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Part A is open label Part B and Part C are a double-blinded study. Study participants and their caregivers, investigators and other site staff, and sponsor staff involved in the study team will be blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 in Part A 		All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1
  • Drug: Cohort 1 in Part A
    Dose 1 KAN-101 Intravenous (IV) infusion
    Other names:
    • KAN-101
Experimental
Cohort 2 in Part A 		All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2
  • Drug: Cohort 2 in Part A
    Dose 2 KAN-101 Intravenous (IV) infusion
    Other names:
    • KAN-101
Placebo Comparator
Group 1 in Part B and Part C 		All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of placebo
  • Other: Placebo: Group 1 in Part B and Part C
    Placebo Intravenous (IV) infusion
    Other names:
    • Placebo
Experimental
Group 2 in Part B and Part C 		All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3
  • Drug: Group 2 in Part B and Part C
    Dose 3 KAN-101 Intravenous (IV) infusion
    Other names:
    • KAN-101
Experimental
Group 3 in Part B and Part C 		All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4
  • Drug: Group 3 in Part B and Part C
    Dose 4 KAN-101 Intravenous (IV) infusion
    Other names:
    • KAN-101
Experimental
Group 4 in Part B and Part C 		All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5
  • Drug: Group 4 in Part B and Part C
    Dose 5 KAN-101 Intravenous (IV) infusion
    Other names:
    • KAN-101

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Study Coordinator
205-962-6865

More Details

Status
Recruiting
Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Study Contact

Kanyos Bio, Inc. (a wholly owned subsidiary of Anokion S.A.)
+1 857-320-6607
clinicaltrials@anokion.com

Detailed Description

The study is a 3-part, multicenter Phase 1b/2 study of KAN-101 in participants with Celiac Disease (CeD) on a gluten free diet (GFD). The 3 parts include: - Part A - Open-label, multiple ascending dose - Part B - Double-blind, placebo-controlled, parallel design - Part C - Double-blind, placebo-controlled, parallel design Part A is a Phase 1b, open-label, multiple ascending dose (MAD) study design to assess the safety, tolerability, and pharmacokinetics (PK) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed CeD. Up to 12 participants who meet study inclusion/exclusion criteria will receive 1 of 2 dose levels of KAN-101. The overall study duration will be about 56 days, including up to 28 days of screening, 7 days of treatment and 21 days of follow up. There will be a gluten challenge test (GC) on Day 15. Parts B and C are Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response following GC, safety, tolerability, and PK of KAN-101 in adult participants with histology-confirmed CeD. Approximately 16 participants (4 participants per dose group) will be enrolled in Part B and 104 participants (26 participants per dose group) enrolled into Part C. Participants will be randomized 1:1:1:1 and stratified by participation in a biopsy substudy to 4 treatment groups: placebo and 3 treatment groups with KAN-101 doses based on information obtained from Part A.