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Assessment of KAN-101 in Celiac Disease (ACeD)

K

Kanyos Bio

Status and phase

Completed
Phase 1

Conditions

Celiac Disease

Treatments

Drug: Placebo
Drug: KAN-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04248855
KAN-101-01

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

41 participants in 7 patient groups

SAD Cohort 1
Experimental group
Description:
All enrolled patients will receive one dose of KAN-101 Dose A
Treatment:
Drug: KAN-101
SAD Cohort 2
Experimental group
Description:
All enrolled patients will receive one dose of KAN-101 Dose B
Treatment:
Drug: KAN-101
SAD Cohort 3
Experimental group
Description:
All enrolled patients will receive one dose of KAN-101 Dose C
Treatment:
Drug: KAN-101
SAD Cohort 4
Experimental group
Description:
All enrolled patients will receive one dose of KAN-101 Dose D
Treatment:
Drug: KAN-101
MAD Cohort 5
Experimental group
Description:
All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
Treatment:
Drug: KAN-101
Drug: Placebo
MAD Cohort 6
Experimental group
Description:
All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
Treatment:
Drug: KAN-101
Drug: Placebo
MAD Cohort 7
Experimental group
Description:
All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
Treatment:
Drug: KAN-101
Drug: Placebo

Trial documents
2

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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