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

StatusRecruiting
PhasePhase 1/2
Started
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Record status
This record was last updated August 13, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jun 19, 2025 to May 31, 2026v3 Show 4 more changesShow less
    • Enrollment target: 118 to 138
    • Study completion date: Jun 19, 2025 to Jan 31, 2027
    • Eligibility criteria expanded, about 18 words
    • Site details revised at 11 of 16 sites
  2. Secondary endpoints revised (2)
    • Collaborators reordered
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06249919
Lead Sponsor Neuracle Science Co., LTD.
Collaborators: Samsung Medical Center, Severance Hospital, Korea University Anam Hospital
Conditions
(from sponsor)		 Seneorineural Deafness, Sudden Sensorineural Hearing Loss
Related terms Hearing Loss, Hidden, Hearing Loss, Sensorineural, Hearing Loss, Sudden
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov