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

The results of this phase 1 clinical trial suggest that the intratympanic delivery of AC102 is a safe and well-tolerated approach for drug delivery to the inner ear in healthy volunteers with normal hearing. As temporary, volume-dependent, conductive hearing losses were observed in the higher frequencies, it is recommended that patients are counseled on a short-term increase in hearing thresholds following injection for conditions such as sudden hearing loss.