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

RecruitingPhase 1, Phase 2Ages 19 Years - 70 YearsAllNeuracle Science Co., LTD.
NCT06249919 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • NS101
  • Placebo
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Where

16 sites
SCH University Hospital Bucheon
Bucheon-si, South Korea
Chonam National University Hospital
Gwangju, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Myongji Hospital
Ilsan, South Korea
Pusan National University Hospital
Pusan, South Korea
Hallym Sacred Heart Hospital
Pyeongchon, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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