Sorrento Therapeutics, Inc. (NASDAQ:SRNE, ", , Sorrento", , ))))) today announced that it has received clearance from the FDA for its investigational new drug application (IND) for intranasal (IN) STI-9199 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers.
The Phase 1 study will be at a single clinical site in San Diego and will be followed by multinational (USA, UK and Mexico) Phase 2/3 trials. Sorrento plans to discuss with the FDA the most appropriate end-points for the pivotal study that could result in an Emergency Use Authorization (EUA), if the trials meet the efficacy end-points of the pivotal study.