Phase 1 Study of SPT-2101 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere's Disease
A Prospective, Placebo Controlled, Single-Blind Phase 1 Study of SPT-2101 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere's Disease (SPT-2101 Safety in Meniere’s Disease Study)
Spiral Therapeutics Australia Pty Ltd
40 participants
Oct 11, 2021
Interventional
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Age 18 years to 85 years (inclusive) at the time of screening
- Provides written informed consent prior to participation in any study procedure
- Has a diagnosis of unilateral Definite Meniere's disease defined by the Classification Committee of the Bárány Society or the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
- Self-reports active, definitive vertigo (lasting 20 minutes or more) in the 3 months prior to screening and records 2 or more Definitive Vertigo Days in the lead-in period.
- Has documented acquired asymmetric sensorineural hearing loss, as reported by the patient or documented by audiometric testing
Exclusion Criteria5
- Ongoing chronic inflammatory or infectious middle ear disease
- Active infection in the ear, sinuses, or upper respiratory system
- Current tympanic membrane perforation, including ventilation tube, in the affected ear.
- Active benign paroxysmal positional vertigo (BPPV) symptoms
- History of superior canal dehiscence
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Interventions
SPT-2101 is an investigational drug designed for intratympanic (IT) administration. It is composed of a chemically crosslinked hydrogel containing a suspension of dexamethasone. Topical anesthetic will be applied to the subject’s ear drum and/or ear canal approximately 30 minutes prior to planned study drug administration, or until therapeutic effect is achieved. SPT-2101 will be delivered to the middle ear via IT administration by an ENT otolaryngologist under direct visualization. The dose level planned is 3 mg of dexamethasone to be administered in a volume of 50 microliter of SPT-2101 containing 6% dexamethasone as a single dose with 24 weeks of post-administration follow-up. An IT injection of 50 µL of sterile isotonic saline will be performed. The study drug will be prepared on site by study personal as per the Instructions for Use.
Locations(4)
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ACTRN12621000964819