NCT04961099

Phase I Clinical Study of HY01 in Patients

Phase I Clinical Study on the Safety, Tolerance, Efficacy and Pharmacokinetics of Repeated Intratympanic HY01 in Patients With Sudden Sensorineural Hearing Loss

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Heyu (Suzhou) Pharmaceutical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sudden Sensorineural Hearing Loss

Interventions

Type	Name	Description
DRUG	HY01	low-dose group: HY01 10mg（20mg/ml）, administrated on D1, D4 and D7 high-dose group: HY01 20mg（40mg/ml）, administrated on D1, D4 and D7

Timeline

• Start date: 2021-06-23
• Primary completion: 2021-10-31
• Completion: 2022-06-30
• First posted: 2021-07-14
• Last updated: 2021-07-14

Locations

1 site across 1 country: China