Phase 1 Study of SPT-2101 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere's Disease

This is a single-blind, placebo controlled, single-dose study to evaluate the safety, tolerability, and PK profile of SPT-2101 following a single IT administration. In all study subjects, SPT-2101 or saline will be delivered unilaterally (one ear will remain untreated). Subjects will enter a 4-week (+/- 2 weeks) lead in period. During this time, subjects will complete a daily patient diary to document baseline vertigo episodes and complete additional laboratory testing. Subjects will then be further screened based on laboratory results and vertigo diary entries. Eligible subjects will return for additional baseline assessments and treatment on Day 1. Cohort 1: A first cohort of subjects (up to 10) will receive SPT-2101 administration in an open-label manner. Cohort 2: A second cohort of subjects (up to 30) will be randomized 1:1 to either: • Arm 1: Subjects receive IT administration of SPT-2101 or • Arm 2: Subjects receive a placebo involving IT administration of saline using a sham procedure. Following study drug administration or sham procedure, subjects will be discharged from the clinic and will return 24 hours post-administration for safety assessments (Day 2). Subjects will have additional follow up visits at Day 8, Day 15, Day 29, Day 57, Day 85, and Day 169. At Day 85, subjects in the placebo arm who meet prespecified criteria will be eligible to receive SPT-2101 in an open label manner. Placebo subjects who cross over to SPT-2101 treatment will restart the study follow-up schedule at Day 2 following the study schedule for Cohort 1.