Assessment of Safety, Tolerability, Pharmacokinetics, and Volume-Dependent Conductive Hearing Loss in Healthy Volunteers: First-in-Human, Open-Label, Placebo-Controlled Study of a Single Intratympanic Injection of AC102
Abstract
Objective: The objective of this study was to assess the safety and tolerability of the intratympanic delivery of AC102, a novel pharmaceutical therapy based on a thermosensitive gel for preventing and treating a range of hearing impairments, including sudden sensorineural hearing loss. We studied this in healthy, normal-hearing volunteers to evaluate any change in hearing thresholds.
Study design: An open-label, placebo-controlled, ascending single-dose, multicenter phase 1 clinical trial.
Setting: The study was conducted in two centers (blinded for reviewing purposes).
Subjects: Forty-two normal-hearing healthy volunteers younger than 40 years of age were eligible for enrollment in the study.
Intervention: A single intratympanic injection of a thermosensitive gel, either a placebo or containing AC102, to the middle ear.
Main outcome measure: The primary objective of this study was to assess the safety and tolerability of a single intratympanic injection of ascending volume of placebo and ascending volume and concentration of AC102. The secondary objective was to determine single-dose pharmacokinetics of intratympanically injected AC102 and to evaluate any change in hearing thresholds in healthy male and female subjects.
Results: The intratympanic delivery of AC102 thermogel was safe and well tolerated in healthy volunteers with normal hearing, with no permanent adverse events recorded. A mild and temporary volume-dependent conductive hearing loss in the higher frequencies…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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