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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

November 15, 2022

Primary Completion Date

November 29, 2024

Study Completion Date

May 19, 2025

Conditions
Celiac Disease
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

Trial Locations (36)

1023

Optimal Clinical Trials, Auckland

2560

Campbelltown Hospital, Campbelltown

3050

The Royal Melbourne Hospital, Parkville

3110

P3 Research - Tauranga, Tauranga

3128

Box Hill Hospital, Box Hill

3204

Waikato Hospital, Hamilton

4066

Wesley Research Institute, Auchenflower

5000

Royal Adelaide Hospital, Adelaide

5032

P3 Research - Palmerston North, Paraparaumu

6021

P3 Research - Wellington, Wellington

6056

St John of God Midland Public and Private Hospitals, Midland

9016

P3 Research - Dunedin, Dunedin

10032

Celiac Disease Center at Columbia University, New York

17033

Penn State Milton S. Hershey Medical Center, Hershey

27607

North Carolina Clinical Research, Raleigh

30328

Agile Clinical Research Trials, Sandy Springs

33705

GCP Research, St. Petersburg

35233

University of Alabama at Birmingham, Birmingham

37212

Vanderbilt University Medical Center, Nashville

43213

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

44060

Great Lakes Gastroenterology Research, LLC, Mentor

44145

Northshore Gastroenterology Research, LLC, Westlake

46202

Indiana University Health University Hospital, Indianapolis

52242

University of Iowa, Iowa City

55114

Prism Research LLC dba Nucleus Network, Saint Paul

55905

Mayo Clinic, Rochester

60612

Rush University Medical Center, Chicago

61761

Sneeze, Wheeze & Itch Associates, LLC, Normal

63110

Washington University School of Medicine, St Louis

68114

Quality Clinical Research, Omaha

76712

Digestive Research of Central Texas, Waco

77030

The University of Texas Health Science Center at Houston, Houston

84088

Velocity Clinical Research, Salt Lake City, West Jordan

84405

Advanced Research Institute, Ogden

92801

Anaheim Clinical Trials, LLC, Anaheim

0622

PCRN Trials, Takapuna

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

INDUSTRY

NCT05574010 - A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it) | Biotech Hunter | Biotech Hunter