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

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, New Zealand, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

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.

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 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

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 and Part C

Placebo Intravenous (IV) infusion

Drug: - Group 2 in Part B and Part C

Dose 3 KAN-101 Intravenous (IV) infusion

Drug: - Group 3 in Part B and Part C

Dose 4 KAN-101 Intravenous (IV) infusion

Drug: - Group 4 in Part B and Part C

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.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Site Contact

Study Coordinator

clinicaltrials@anokion.com

205-962-6865

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

Recruiting

Address

GCP Research

Saint Petersburg, Florida, 33705

Site Contact

Study Coordinator

clinicaltrials@anokion.com

727-520-1427

Agile Clinical Research Trials, Sandy Springs, Georgia

Status

Recruiting

Address

Agile Clinical Research Trials

Sandy Springs, Georgia, 30328

Site Contact

Study Coordinator

clinicaltrials@anokion.com

404-400-2255

Sneeze, Wheeze & Itch Associates, LLC, Normal, Illinois

Status

Recruiting

Address

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, 61761

Site Contact

Study Coordinator

clinicaltrials@anokion.com

309-452-0995

Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Health University Hospital

Indianapolis, Indiana, 46202

Site Contact

Study Coordinator

clinicaltrials@anokion.com

317-278-9294

University of Iowa, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa

Iowa City, Iowa, 52242

Site Contact

Study Coordinator

clinicaltrials@anokion.com

319-356-3935

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Study Coordinator

clinicaltrials@anokion.com

507-284-3075

Prism Research LLC dba Nucleus Network, Saint Paul, Minnesota

Status

Recruiting

Address

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114

Site Contact

Study Coordinator

clinicaltrials@anokion.com

651-300-2888

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Study Coordinator

clinicaltrials@anokion.com

314-747-5366

Quality Clinical Research, Omaha, Nebraska

Status

Recruiting

Address

Quality Clinical Research

Omaha, Nebraska, 68114

Site Contact

Study Coordinator

clinicaltrials@anokion.com

402-934-0044

North Carolina Clinical Research, Raleigh, North Carolina

Status

Recruiting

Address

North Carolina Clinical Research

Raleigh, North Carolina, 27607

Site Contact

Study Coordinator

clinicaltrials@anokion.com

919-881-0309

Columbus, Ohio

Status

Recruiting

Address

Aventiv Research, Inc. d/b/a Centricity Research

Columbus, Ohio, 43213

Site Contact

Study Coordinator

clinicaltrials@anokion.com

614-501-6164

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Site Contact

Study Coordinator

clinicaltrials@anokion.com

440-205-1225

Westlake, Ohio

Status

Recruiting

Address

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145

Site Contact

Study Coordinator

clinicaltrials@anokion.com

440-250-7584

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Site Contact

Study Coordinator

clinicaltrials@anokion.com

615-936-1745

Houston, Texas

Status

Recruiting

Address

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

Site Contact

Study Coordinator

clinicaltrials@anokion.com

713-500-8908

Digestive Research of Central Texas, Waco, Texas

Status

Recruiting

Address

Digestive Research of Central Texas

Waco, Texas, 76712

Site Contact

Study Coordinator

clinicaltrials@anokion.com

210-900-5821

Advanced Research Institute, Ogden, Utah

Status

Recruiting

Address

Advanced Research Institute

Ogden, Utah, 84405

Site Contact

Study Coordinator

clinicaltrials@anokion.com

801-409-2040

West Jordan, Utah

Status

Recruiting

Address

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088

Site Contact

Study Coordinator

clinicaltrials@anokion.com

801-542-8190

International Sites

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Site Contact

Study Coordinator

clinicaltrials@anokion.com

+61 8 7074 2200

Box Hill Hospital, Box Hill, Victoria, Australia

Status

Recruiting

Address

Box Hill Hospital

Box Hill, Victoria, 3128

Site Contact

Study Coordinator

clinicaltrials@anokion.com

043-870-2279

The Royal Melbourne Hospital, Parkville, Victoria, Australia

Status

Recruiting

Address

The Royal Melbourne Hospital

Parkville, Victoria, 3050

Site Contact

Study Coordinator

clinicaltrials@anokion.com

(03) 9342-8076

Midland, Western Australia, Australia

Status

Recruiting

Address

St John of God Midland Public and Private Hospitals

Midland, Western Australia, 6056

Site Contact

Study Coordinator

clinicaltrials@anokion.com

+618 9462 4000

PCRN Trials, Takapuna, Auckland, New Zealand

Status

Recruiting

Address

PCRN Trials

Takapuna, Auckland, 0622

Site Contact

Study Coordinator

clinicaltrials@anokion.com

649-242-3321

P3 Research - Tauranga, Tauranga, Bay Of Plenty, New Zealand

Status

Recruiting

Address

P3 Research - Tauranga

Tauranga, Bay Of Plenty, 3110

Site Contact

Study Coordinator

clinicaltrials@anokion.com

647-579-0453

P3 Research - Hawke's Bay, Hastings, Hawke's Bay, New Zealand

Status

Withdrawn

Address

P3 Research - Hawke's Bay

Hastings, Hawke's Bay, 4122

P3 Research - Dunedin, Dunedin, Otago, New Zealand

Status

Recruiting

Address

P3 Research - Dunedin

Dunedin, Otago, 9016

Site Contact

Study Coordinator

clinicaltrials@anokion.com

643-974-8174

P3 Research - Palmerston North, Paraparaumu, Wellington, New Zealand

Status

Recruiting

Address

P3 Research - Palmerston North

Paraparaumu, Wellington, 5032

Site Contact

Study Coordinator

clinicaltrials@anokion.com

646-241-8009

Optimal Clinical Trials, Auckland, New Zealand

Status

Recruiting

Address

Optimal Clinical Trials

Auckland, , 1023

Site Contact

Study Coordinator

clinicaltrials@anokion.com

649-303-4987

Waikato Hospital, Hamilton, New Zealand

Status

Recruiting

Address

Waikato Hospital

Hamilton, , 3204

Site Contact

Study Coordinator

clinicaltrials@anokion.com

+64 2 154 9659

P3 Research - Wellington, Wellington, New Zealand

Status

Recruiting

Address

P3 Research - Wellington

Wellington, , 6021

Site Contact

Study Coordinator

clinicaltrials@anokion.com

644-801-0002

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