This study is to test the safety and effectiveness of FB102 in well-controlled coeliac disease (those on a strict gluten free diet) following a gluten consumption challenge.
About this study
Coeliac disease doesn’t just affect what you eat, it impacts your entire lifestyle. Even with a gluten-free diet, many individuals continue to suffer from symptoms and complications. This disease affects thousands of people across Australia with symptoms including pain, bloating, other gut related issues and chronic fatigue.
This study aims to evaluate the safety and effectiveness of an investigational medicinal product called FB102, in Coeliac disease patients who are undergoing a gluten challenge. FB102 is an experimental drug being developed as a potential new treatment for patients with coeliac disease. There is a chance you may receive a placebo.
By participating in this clinical trial, you'll be contributing to vital research that aims to go beyond just managing symptoms through diet. Your involvement could help pave the way for better treatments, improving quality of life for individuals affected by Coeliac disease.
Anticipated enrolment close date: December 2026
Who can take part
You may be eligible to participate if you:
- are aged between 18 to 70 years
- have biopsy confirmed asymptomatic Coeliac disease
- have been managing Coeliac disease symptoms with a gluten-free diet
- are willing to participate in a gluten challenge
What's involved for you
If you agree to take part in the study and the study is suitable for you, your participation will last approximately 33 weeks (8 months), and you will be required to return to the study site for up to 16 study visits.
Required assessments and tests include:
- physical examinations (height, weight, BMI)
- electrocardiogram (ECG)
- vital signs (blood pressure, heart rate, body temperature, breathing rate)
- laboratory tests
- gastroscopy
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by an Australian registered and certified HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2025). This statement protects the interests of people who agree to participate in human research studies.