Trial reportOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2025
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.
Trial report in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Review
- Application of neurodegenerative disease treatment strategies in tinnitus: mechanisms, translation, and prospects.Frontiers in aging neuroscience · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe 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
designAn open-label, placebo-controlled, ascending single-dose, multicenter phase 1 clinical trial.
settingThe 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.
interventionA single intratympanic injection of a thermosensitive gel, either a placebo or containing AC102, to the middle ear.
main outcome measureThe 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.
resultsThe 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 was observed irrespective of AC102 or placebo, which did not result in long-term changes in hearing. Other transient adverse events related to the injection procedure were largely similar between placebo gel and AC102 suspension, consisting mainly of mild ear discomfort, tinnitus, otalgia, and the formation of a droplet of blood at the injection site.
conclusionsThe 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.