Vaxart Gets FDA Sign-Off on Phase 1 Clinical Trial for Its Coronavirus Vaccine
Vaxart (NASDAQ: VXRT) moved one step closer to producing clinical trial data for its oral coronavirus vaccine. The Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for a phase 1 clinical trial. The FDA reviews INDs to make sure there aren't any safety concerns in the preclinical animal data before allowing companies to start clinical trials.
The study, which is scheduled to start enrolling patients later this month, will test two doses of the vaccine in adults ages 18 to 55. The company didn't say how many participants it plans to enroll nor how far apart the doses will be given.
As an early stage study, the primary objective is to check for safety, but Vaxart also plans to look at the immune response, such as the creation of antibodies against the novel coronavirus, and even whether the participants develop COVID-19, the disease caused by the novel coronavirus.
Source Fool.com
