Phase I Clinical Study of HY01 in Sudden Sensorineural Hearing Loss Patients

The incidence rate of sudden deafness is increasing year by year, which can cause severe hearing loss. Intratympanic HY01 can increase the local drug concentration in the ear, which is equal to or better than that in the treatment of sudden sensorineural hearing loss, and reduce the systemic drug concentration at the same time. It has obvious clinical value for the treatment of hormone forbidden population.

HY01 is one of glucocorticoid drugs. In this study, we designed low-dose group and high-dose group of HY01, and enrolled 6 patients with sudden sensorineural hearing loss for salvage therapy in each group. HY01 will be administrated on D1, D4 and D7 . The trial will be ended 30 days after the first administration.

After determining the safety of low-dose, the patients in the high-dose group will be enrolled. The safety observation indexes included systemic Routine Indexes and otology indexes, and the efficacy and pharmacokinetics were observed at the same time.

➡️ https://clinicaltrials.gov/ct2/show/NCT04961099

 

Will this be affecting tinnitus in any way? As far as I can see, the exclusion criteria is listed the following:

1. Patients with previous or current ear related diseases may affect the judgment of adverse events, including but not limited to chronic ear infection, cholesteatoma, Meniere's disease, otosclerosis, fluctuating hearing loss, acoustic trauma, autoimmune hearing loss, radiation-induced hearing loss, syphilitic deafness, endolymphatic hydrops, hearing loss caused by otological surgery Suspected retrocochlear lesions, suspected perilymph fistula or membrane rupture, perilymph fistula or barotrauma, acoustic neuroma, synchronous tinnitus (possibly caused by glomus jugulare tumor), skull, face or temporal bone abnormalities;

 

If you mean will the exclusion criteria likely exclude groups of people who have got tinnitus from participating, then the answer is likely to be no, it will not.

Noting cases of sudden hearing loss to date, a lot of them have tinnitus as a result of it.

 

The study ended about 2 months ago, I wonder when we'll be getting results.