TEVA Study - Wesley Research Institute
Wesley Research Institute
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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 celiac disease with intestinal biopsy 
  • Have symptoms of celiac 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

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