FB102 - Wesley Research Institute

The purpose of the study is to assess the safety of FB102 and better understand the positive and negative effects of the drug on participants with coeliac disease.

Research Objectives

Status

Current

Recruitment

Open

Total participants required

8

Study location

Wesley Research Institute

Study type

Industry Sponsored

Patient group

Coeliac Disease

About this clinical trial

This study aims to test FB102, a potential new treatment for autoimmune and inflammatory diseases like graft-versus-host disease (GvHD), vitiligo, and coeliac disease (CeD). It will evaluate both the positive and negative effects of FB102 on participants and their conditions. Part C of the study, in which you are invited to participate, focuses specifically on assessing the safety and effectiveness of FB102 in individuals with coeliac disease. The research is conducted by Forte Biosciences Inc. and sponsored in Australia by Forte Biosciences Australia Pty Ltd. Avance Clinical Pty Ltd, a Clinical Research Organisation (CRO), manages the project in Australia.

Eligibility

Aged 18-65 years (inclusive)
Have a coeliac disease diagnosis (biopsy and blood test results) at least 12 months before screening
Body mass index (BMI) between 16 and 32 kg/m2 (inclusive)
Body weight between 50 and 100 kg for men, 45 and 95 kg for women (inclusive)
On a gluten free diet for at least 12 months.
Genotype compatible with Coeliac disease (HLA DQ2/DQ8)
Persons of non-childbearing potential are at least 12 months postmenopausal

  Lead investigator  
          Dr Jennifer Schafer      

  Clinical trial coordinator  
          Leah Hingston      

Technical title

A Three-Part, Multi-Centre, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of FB102 After Single and Multiple Ascending Dose Administrations in Healthy Participants and Multiple Dose Administration in Participants with Celiac Disease.