MOZART
Are You Eligible?The purpose of this study is to evaluate the safety of MTX-101 and better understand how this drug behaves in and affects the human body.
Research Objectives
Status
Recruitment
Total participants required
Study location
Study type
Patient group
About this clinical trial
MTX-101 is an antibody/protein that targets regulatory CD8 T cells, which help control inflammation. In some individuals, these cells malfunction, leading to uncontrolled inflammation and autoimmune diseases. MTX-101 is administered via infusion and binds to KIR2DL and CD8 receptors on regulatory CD8 T cells. This restores their function, reducing inflammation and potentially managing autoimmune diseases like coeliac disease. Wesley Research Institute is participating in Part B of this study. Part B CeD will evaluate two dose levels across two cohorts (B8 and B9), each enrolling 6–10 participants. Cohort B8 has two groups: B8 Group 1 receives MTX-101 on Days 1 and 29, then placebo on Day 57, while B8 Group 2 gets placebo first, then MTX-101 on Days 29 and 57. Cohort B9 follows a similar structure but without the Day 57 dose.
This clinical trial does not require a gluten challenge.
Trial registration information – https://clinicaltrials.gov/study/NCT06324604
Eligibility
- Aged 18-65 years (inclusive)
- No existing chronic or autoimmune diseases
- Body mass index (BMI) between 18 and 32 kg/m2 (inclusive)
- Body weight between 45 and 100 kg (inclusive)
- Have a coeliac disease diagnosis (biopsy and blood test results)
- On a gluten free diet for at least a month
Lead investigator
- Dr James Daveson
Clinical trial coordinator
- Leah Hingston
Technical title
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
Register your interest
If you would like more information about this clinical trial, please complete the contact form below.