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.
Authors
- Ronald J. E. Pennings (ORCID: https://orcid.org/0000-0001-5517-9683)
- Hans Rommelspacher
- Cris Lanting (ORCID: https://orcid.org/0000-0001-9397-7766)
- Christoph Arnoldner (ORCID: https://orcid.org/0000-0003-0066-810X)
- Markus Zeitlinger (ORCID: https://orcid.org/0000-0002-1873-3953)
- Sybren M. M. Robijn (ORCID: https://orcid.org/0000-0001-5082-0005)
- Michael Nieratschker
- Reimar Schlingensiepen
- Martin Bauer (ORCID: https://orcid.org/0000-0003-4818-1560)
- Sandra Ahoud-Schoenmakers
- Edith Lackner
- Christin Galetzka
- Alena Meis
Institutions
- Radboud University Nijmegen (NL)
- Radboud University Medical Center (NL)
- Radboud Institute for Molecular Life Sciences (NL)
- CellAct Pharma (Germany) (DE)
- Medical University of Vienna (AT)
Publication Details
- Journal
- Otology & Neurotology
- Published
- 2025-08-11
- DOI
- https://doi.org/10.1097/mao.0000000000004568
- Citations
- 2
- Primary Topic
- Vestibular and auditory disorders
- Type
- article
- Field-Weighted Citation Impact
- 1.68