- 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 medications must go through multiple phases of clinical trials before they can be approved by regulators for use in people. The AVALON Study is a Phase 1 clinical trial, which means the study medication is being tested in a small group of patients with celiac disease for the first time. The purpose of this trial is to evaluate the safety and tolerability of the study medication, as well as how the body responds to it.
