A Phase 1B Open-label/Phase 2 Double-blind Placebo- Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients With Celiac Disease (CeD)
Status: Terminated
Location: See all (36) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
Anaheim Clinical Trials, LLC
Anaheim
Florida
GCP Research
St. Petersburg
Georgia
Agile Clinical Research Trials
Sandy Springs
Iowa
University of Iowa
Iowa City
Illinois
Rush University Medical Center
Chicago
Sneeze, Wheeze & Itch Associates, LLC
Normal
Indiana
Indiana University Health University Hospital
Indianapolis
Minnesota
Mayo Clinic
Rochester
Prism Research LLC dba Nucleus Network
Saint Paul
Missouri
Washington University School of Medicine
St Louis
North Carolina
North Carolina Clinical Research
Raleigh
Nebraska
Quality Clinical Research
Omaha
New York
Celiac Disease Center at Columbia University
New York
Ohio
Aventiv Research, Inc. d/b/a Centricity Research
Columbus
Great Lakes Gastroenterology Research, LLC
Mentor
Northshore Gastroenterology Research, LLC
Westlake
Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
The University of Texas Health Science Center at Houston
Houston
Digestive Research of Central Texas
Waco
Utah
Advanced Research Institute
Ogden
Velocity Clinical Research, Salt Lake City
West Jordan
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Wesley Research Institute
Auchenflower
Box Hill Hospital
Box Hill
Campbelltown Hospital
Campbelltown
St John of God Midland Public and Private Hospitals
Midland
The Royal Melbourne Hospital
Parkville
New Zealand
Optimal Clinical Trials
Auckland
P3 Research - Dunedin
Dunedin
Waikato Hospital
Hamilton
P3 Research - Palmerston North
Paraparaumu
PCRN Trials
Takapuna
P3 Research - Tauranga
Tauranga
P3 Research - Wellington
Wellington
Time Frame
Start Date: 2022-11-15
Completion Date: 2025-05-19
Participants
Target number of participants: 126
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Collaborators: Pfizer