A study of AX-024.HCl to evaluate food effect and multidosing in males
Research type
Research Study
Full title
A safety, tolerability, and pharmacokinetic clinical trial of AX-024.HCl to evaluate A) potential food effect and B) multi-dosing in healthy male subjects
IRAS ID
182053
Contact name
Robert Adams
Contact email
Sponsor organisation
Artax Biopharma
Eudract number
2015-001791-21
Duration of Study in the UK
0 years, 4 months, 3 days
Research summary
This is a safety, tolerability, and pharmacokinetic clinical trial of AX-024.HCl to evaluate potential food effect (Part A) and multi-dosing (Part B) in healthy male subjects.
Artax Biopharma has developed a novel drug whose therapeutic target is the T-cell receptor macromolecular complex (signalosome). It is widely accepted that T-cells are vital to human immune response as they orchestrate the immune system by controlling other T-cell subsets, B-cells and innate immune responses. Moreover, scientific evidence points to cytosolic protein, Nck, recruitment as a fundamental early step in TCR signalling, representing a target to modulate immune response.
Artax Biopharma has employed a virtual screening and combinatorial chemistry approach to identify and engineer molecules targeting the Nck-TCR interaction in a selective manner. This has led to the generation of a family of molecules which are the first low molecular weight inhibitors of the TCR-Nck interaction that selectively prevents TCR-triggered T-cell activation with an IC50 (half maximal inhibitory concentration) below 0.1 nM. For example, treatment with AX-024.HCl has been shown to inhibit human T-cell proliferation triggered by anti-CD3 and shows high selectivity and efficacy in vitro and in vivo.
The purpose of this study is to examine the effect of food on AX-024.HCl safety, tolerability and pharmacokinetic parameters and then to also examine these same aspects following multi-dosing; i.e. singla oral dose daily for 10 days.
REC name
Wales REC 2
REC reference
15/WA/0173
Date of REC Opinion
10 Jun 2015
REC opinion
Further Information Favourable Opinion