drugset / Trial / NCT04961099
Phase I Clinical Study of HY01 in Patients
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-06-23
- Primary completion
- 2021-10-31
- Completion
- 2022-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HY01 | Unknown | 10 mg | Intrathecal |
| Subject | HY01 | Unknown | 20 mg | Intrathecal |