A Phase I/II multiple ascending dose open-label safety and efficacy study of the Notch Inhibitor LY3056480 in patients with mild to moderate SNH

Audion Therapeutics BV0 个研究点目标入组 59 人开始时间: 2017年5月16日最近更新: 2024年3月18日

研究概览

2024 Results article in https://doi.org/10.1038/s41467-024-45784-0 (added 04/03/2024)

•1. Male or female between 18 and 80 years of age
•2. A primary complaint of hearing loss of ? 10 years in duration, the history suggesting this hearing-loss to be of age-related, noise-induced or idiopathic origin
•3. A bilateral, symmetrical (<15 dBHL difference) SNHL with a pure-tone average threshold across the frequencies 0.5, 1, 2, 4 and 8 kHz of between 25 and 60 dBHL with 2 or more frequencies less than 60 dBH

•1. Presenting with a primary complaint of tinnitus
•2. A ‘true’ air-bone gap >15 dBHL in 3 or more contiguous frequencies between 0.5, 1, 2, 4 kHz
•3. History of suspected or diagnosed genetic cause of hearing loss
•4. Suspected or known diagnosis of inner ear pathology, congenital hearing loss, fluctuating hearing loss, Ménière’s disease, or secondary endolymphatic hydrops, perilymph fistula, cochlear barotrauma, autoimmune hearing loss, radiation-induced hearing loss, retro-cochlear lesion
•5. Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery
•6. Any therapy known as ototoxic within 12 months of screening

发起方