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

Phase 1/2 Terminated 128 enrolled Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA Pfizer · collab

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start: 2022-11-15
Primary completion: 2024-11-29
Completion: 2025-05-19

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Publications

Background Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.
Muhammad A, Xiao Y, Ahmad YM, Tang R, Zhang Y, Yuan Q, Xiao X. Reprogramming Pathogenic Immune Memory through Inverse Vaccination in Autoimmune Kidney Disease. J Am Soc Nephrol. 2026 Feb 27. doi: 10.1681/ASN.0000001070. Online ahead of print. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KAN-101	Peptide	—	Intravenous