A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Seneorineural Deafness, Sudden Sensorineural Hearing Loss

In brief

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.

Key facts

Study ID

NCT06249919

Run by

Neuracle Science Co., LTD.

People needed

138

Starts

2024-01-19

Expected to finish

2027-01-31

Last updated by the study team

2025-08-13

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• unilateral ideopathic SSNHL greater than 45dB at the average of 4 frequencies in PTA (contralateral hearing is less than 30dB)
• Subject who has completed investigator-recognized standard treatment within 30 days of symptom onset and is able to undergo randomization visit within 35 days.
• Subjects who, in the opinion of the investigator, have received sufficient systemic steroid therapy for approximately 2 weeks recovery
• A combination regimen consisting of approximately 2 weeks of systemic steroid therapy and intratympanic steroid administration

You may not qualify if…

• other otologic or systemic diseases
• retrocochlear lesion

Where it is running

• Wonju Severance Christian Hospital — Wŏnju, South Korea (enrolling)
• Chonam National University Hospital — Gwangju, South Korea (enrolling)
• Inje University Ilsan Paik Hospital — Ilsan, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Yonsei University Severance Hospital — Seoul, South Korea (enrolling)
• Pusan National University Hospital — Pusan, South Korea (enrolling)
• Hallym Sacred Heart Hospital — Pyeongchon, South Korea (enrolling)
• Seoul National University Bundang Hospital — Seongnam, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Catholic University Seoul St. Mary's Hospital — Seoul, South Korea (enrolling)
• Myongji Hospital — Ilsan, South Korea
• Korea University Anam Hospital — Seoul, South Korea
• SCH University Hospital Bucheon — Bucheon-si, South Korea
• Ajou University Hospital — Suwon, South Korea

Full record on ClinicalTrials.gov

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