Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 70 Years|
- - 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.
- - Refractory celiac disease.
- - HLA-DQ8 genotype.
- - Previous oral gluten challenge within 12 months.
- - Selective IgA deficiency.
- - Diagnosis of Type-1 diabetes.
- - Active gastrointestinal diseases.
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.
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|
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|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Anokion SA|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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
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.