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

NCT05574010 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-03-10

Study results available
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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).

Conditions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

  • Study Director · Anokion SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2024-11-29
Completion
2025-05-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05574010 on ClinicalTrials.gov