Assessment of KAN-101 in Celiac Disease (ACeD)

Study Purpose

A safety study of KAN-101 in patients with celiac disease. The study has two parts: 1. Part A

- first in human study in which patients receive a single dose of KAN-101.

2. Part B - patients will receive three doses of either KAN-101 or placebo

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

Key

Inclusion Criteria:

1. Adults aged 18 to 70 years inclusive. 2. 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. 3. Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes) 4. Has followed a GFD for > 12 months immediately prior to study entry. 5. Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening. 6. Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods. 7. Capable of understanding and complying with protocol requirements. 8. Patient understands and has signed the informed consent form. Key

Exclusion Criteria:

1. Refractory celiac disease. 2. Selective IgA deficiency. 3. Positive for HLA-DQ8 (DQA1*03, DQB1*0302) 4. Previous treatment with tolerance-inducing therapies for celiac disease. 5. Known wheat allergy. 6. Part B only: History of hyperacute or prolonged symptoms following gluten exposure. 7. Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation. 8. History of dermatitis herpetiformis. 9. Pregnant or breastfeeding

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.	NCT04248855
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
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.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease

Additional Details

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: 1. Part A (SAD): Patients will receive a single dose of KAN-101. 2. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

Arms & Interventions

Arms

Experimental: SAD Cohort 1

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

Experimental: SAD Cohort 2

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

Experimental: SAD Cohort 3

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

Experimental: SAD Cohort 4

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

Experimental: MAD Cohort 5

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

Experimental: MAD Cohort 6

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

Experimental: MAD Cohort 7

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

Interventions

Drug: - KAN-101

Intravenous (IV) infusion

Drug: - Placebo

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, Anaheim, California

Status

Recruiting

Address

Anaheim Clinical Trials

Anaheim, California, 92801

Site Contact

Hee Sung Ko

hko@act-trials.com

714-774-7777 #1089

Diablo Clinical Research, Walnut Creek, California

Status