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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 in Part A |
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1 |
|
|
Experimental Cohort 2 in Part A |
All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2 |
|
|
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 |
|
|
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 |
|
|
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 |
|
|
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 |
|
Recruiting Locations
Nashville, Tennessee 37212
Study Coordinator
615-936-1745
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.