Phase I Clinical Study of HY01 in Patients

  • STATUS
    Recruiting
  • participants needed
    12
  • sponsor
    Heyu (Suzhou) Pharmaceutical Technology Co., Ltd
Updated on 16 August 2022

Summary

Phase I clinical study on the safety, tolerance, efficacy and pharmacokinetics of repeated intratympanic HY01 in patients with sudden sensorineural hearing loss. In this study, low-dose group and high-dose group were designed, 6 cases in each group.

Description

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.

Details
Condition Sudden Sensorineural Hearing Loss
Treatment HY01
Clinical Study IdentifierNCT04961099
SponsorHeyu (Suzhou) Pharmaceutical Technology Co., Ltd
Last Modified on16 August 2022

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