About the Study

Barinthus Biotherapeutics North America, Inc. is the study sponsor.

According to the FDA, clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs. Clinical trials help regulators, like the FDA, assess whether new drugs are safe and effective for people to use and to understand how treatments may potentially be used. All [...]

A placebo is an inactive substance with no therapeutic effect that is used to help determine whether results observed are due to the study medication.

This study is the first time VTP-1000 is being tested in humans. VTP-1000 has previously been tested in animal studies. Based on what we have learned about VTP-1000 in animal studies, we are now advancing VTP-1000 to be tested in humans. To date, VTP-1000 has not been approved by a regulatory authority for any indication.

VTP-1000 is administered as an injection to the upper arm. Participants will receive 1 or 2 injections depending on the dose level they receive.

VTP-1000 is an investigational targeted immunotherapy designed to prevent or reduce celiac disease symptoms caused by accidental gluten exposure. The goal of the study drug is to promote tolerance to gluten while preserving the immune system’s overall protective function.