Assessment of KAN-101 in Celiac Disease (ACeD)

A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)

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

Study Overview

• Status: Completed
• Conditions: Celiac Disease
• Intervention / Treatment: Drug: Placebo; Drug: KAN-101

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Florida
    • Aventura, Florida, United States, 33180
      • Innovative Medical Research of South Florida
    • Saint Petersburg, Florida, United States, 33705
      • GCP Research
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Parexel International- EPCU Baltimore
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • West Michigan Clinical Research Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10032
      • Celiac Disease Center at Columbia University
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Aventiv Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-Clinsearch, LLC
  • Utah
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Cohort 1; All enrolled patients will receive one dose of KAN-101 Dose A	Drug: KAN-101; Intravenous (IV) infusion
Experimental: SAD Cohort 2; All enrolled patients will receive one dose of KAN-101 Dose B	Drug: KAN-101; Intravenous (IV) infusion
Experimental: SAD Cohort 3; All enrolled patients will receive one dose of KAN-101 Dose C	Drug: KAN-101; Intravenous (IV) infusion
Experimental: SAD Cohort 4; All enrolled patients will receive one dose of KAN-101 Dose D	Drug: KAN-101; Intravenous (IV) infusion
Experimental: MAD Cohort 5; All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo	Drug: Placebo; Intravenous (IV) infusion; Drug: KAN-101; Intravenous (IV) infusion
Experimental: MAD Cohort 6; All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo	Drug: Placebo; Intravenous (IV) infusion; Drug: KAN-101; Intravenous (IV) infusion
Experimental: MAD Cohort 7; All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo	Drug: Placebo; Intravenous (IV) infusion; Drug: KAN-101; Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)	Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher	Up to 28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Geometric mean of maximum drug concentration (Cmax)	0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
AUC Last	Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)	0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7

Collaborators and Investigators

• Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
• Investigators: Study Director: Study Director, Kanyos Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): October 8, 2021
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Phase 1; Multicenter; Double blind
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: KAN-101-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No