TEVA Study
A Single-Dose Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Characterise the Safety and Tolerability of TEV-53408 Administered Subcutaneously in Adults with Coeliac Disease
Research Objectives
Status
Current
Recruitment
Closed
Total participants required
20
Study location
Wesley Research Institute
Study type
Industry Sponsored
Patient group
Coeliac Disease
About this clinical trial
The aim of this research study is to find out if a single injection of the research medicine, called TEV-53408, is safe and well-tolerated in adults with coeliac disease compared to a placebo injection.
A placebo looks very similar to the research medicine but does not contain any active medicine. Researchers use a placebo to see if a research medicine works better or is safer than not taking anything at all.
TEVA
Eligibility
- Be between 18 and 70 years old
- Have a diagnosis of coeliac disease with intestinal biopsy
- Have symptoms of coeliac disease when exposed to gluten
- Be on (or trying to be on) a gluten-free diet with no to moderate symptoms
- Have a positive HLA DQ2 or HLA DQ8 test
- Received of all regionally required vaccinations recommended for age and concurrent medical conditions and/or agrees to receive prior to participation in the study (if able)
Lead investigator
- A/Prof James Daveson
Experienced investigator
- Dr Jennifer Schafer
Clinical trial coordinators
- Chris Henderson
- Leah Hingston