A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in People With Celiac Disease

Study 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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05574010
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Study Director
Principal Investigator Affiliation	Anokion SA
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease

Additional Details

The study is a 2-part, multicenter Phase 1b/2 study of KAN-101 in participants with Celiac Disease (CeD) on a gluten free diet (GFD). The 2 parts include:

- Part A - Open-label, multiple ascending dose.

- Part B - 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. Part B is a 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. 120 participants (30 participants per dose group) 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.

Arms & Interventions

Arms

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

All eligible Part B participants will receive 3 intravenous (IV) infusions of placebo

Experimental: Group 2 in Part B

All eligible Part B participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3

Experimental: Group 3 in Part B

All eligible Part B participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4

Experimental: Group 4 in Part B

All eligible Part B participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5

Interventions

Drug: - Cohort 1 in Part A

Dose 1 KAN-101 Intravenous (IV) infusion

Drug: - Cohort 2 in Part A

Dose 2 KAN-101 Intravenous (IV) infusion

Other: - Placebo: Group 1 in Part B

Placebo Intravenous (IV) infusion

Drug: - Group 2 in Part B

Dose 3 KAN-101 Intravenous (IV) infusion

Drug: - Group 3 in Part B

Dose 4 KAN-101 Intravenous (IV) infusion

Drug: - Group 4 in Part B

Dose 5 KAN-101 Intravenous (IV) infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Anaheim Clinical Trials, LLC, Anaheim, California

Status

Recruiting

Address

Anaheim Clinical Trials, LLC

Anaheim, California, 92801

Site Contact

Study Coordinator

clinicaltrials@anokion.com

949-295-7809

GCP Research, Saint Petersburg, Florida

Status