Condition: Seneorineural Deafness · Sudden Sensorineural Hearing Loss · Sponsor: Neuracle Science Co., LTD.
The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage therapy. The main questions it aims to answer are: 1. whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of NS101 against FAM19A5 2. whether is it effective in reversing hearing capability in sudden sensorineural hearing loss patients who fails to show sufficient recovery despite of oral standard steroid therapy. Patients and heathly volunteers will be given NS101 15mg/kg or 30mg/kg systemically less than 3 months per protocol. This is placebo controlled, double blinded study, which means there will be a group who receives placebo (i.e. fake drug) for study purpose.
This description comes directly from the study's public registry record.
Yunkyung Choi · +82269490409 · clinical@neuracles.com
Suhyun Cho · +82269490409 · clinical@neuracles.com
Always discuss trial participation with your own doctor first.
| SCH University Hospital Bucheon | Bucheon-si, South Korea | Not Yet Recruiting |
| Chonam National University Hospital | Gwangju, South Korea | Recruiting |
| Inje University Ilsan Paik Hospital | Ilsan, South Korea | Recruiting |
| Myongji Hospital | Ilsan, South Korea | Not Yet Recruiting |
| Pusan National University Hospital | Pusan, South Korea | Recruiting |
| Hallym Sacred Heart Hospital | Pyeongchon, South Korea | Recruiting |
| Seoul National University Bundang Hospital | Seongnam, South Korea | Recruiting |
| Asan Medical Center | Seoul, South Korea | Recruiting |
| Catholic University Seoul St. Mary's Hospital | Seoul, South Korea | Recruiting |
| Korea University Anam Hospital | Seoul, South Korea | Recruiting |
| Korea University Anam Hospital | Seoul, South Korea | Not Yet Recruiting |
| Samsung Medical Center | Seoul, South Korea | Recruiting |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06249919