A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia (RIX)
Objective
Primary Objectives: To assess the effect of bilateral treatment with AAV2-hAQP1 on xerostomia-related symptoms as measured by the Xerostomia-specific Questionnaire (XQ). Key Secondary Objectives: To assess the effect of bilateral treatment with AAV2-hAQP1 on unstimulated whole saliva output (mL/min), To evaluate the safety and tolerability of bilateral treatment with AAV2-hAQP1.