Evaluating NS101 for sudden hearing loss in healthy volunteers and patients
A Phase 1b/2a, Double-blinded, Placebo-controlled, Multiple Doses, 2 Step-up Study Evaluating the Safety, Tolerability, PK/PD and Efficacy of Systemic NS101 in Healthy Volunteers and SSNHL Patients
This study is testing a new treatment called NS101 to see if it can help people with sudden hearing loss who haven't improved with regular steroid treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Neuracle Science Co., LTD. Industry-sponsored |
| Locations | 16 sites (Bucheon-si and 15 other locations) |
| Trial ID | NCT06249919 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to assess the safety, tolerability, and pharmacokinetics of NS101 in healthy volunteers and its efficacy in patients with sudden sensorineural hearing loss (SSNHL). The study is designed in two parts: the first part involves healthy volunteers receiving multiple doses of NS101, while the second part focuses on SSNHL patients who have not adequately responded to standard steroid therapy. Participants will be randomly assigned to receive either NS101 or a placebo in a double-blind manner. The study seeks to determine if NS101 can effectively reverse hearing loss in patients who have not shown sufficient recovery.
Who should consider this trial
Good fit: Ideal candidates include patients with unilateral idiopathic SSNHL who have not responded adequately to oral steroid treatment.
Not a fit: Patients with other otologic or systemic diseases or those with retrocochlear lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from sudden sensorineural hearing loss.
How similar studies have performed: While this approach is exploratory, similar studies targeting sudden sensorineural hearing loss have shown promise, but the specific use of NS101 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Part A: healthy volunteers Part B: Inclusion Criteria: * 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 Exclusion Criteria: * other otologic or systemic diseases * retrocochlear lesion
Where this trial is running
Bucheon-si and 15 other locations
- 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)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Yonsei University Severance Hospital — Seoul, South Korea (Recruiting)
- Ajou University Hospital — Suwon, South Korea (Not_yet_recruiting)
- Wonju Severance Christian Hospital — Wŏnju, South Korea (Recruiting)
Study contacts
- Study coordinator: Yunkyung Choi
- Email: clinical@neuracles.com
- Phone: +82269490409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.