A Phase 1/2 interventional study of NS101 and Placebo in Seneorineural Deafness and Sudden Sensorineural Hearing Loss, sponsored by Neuracle Science Co., LTD.. Recruiting at 16 sites in South Korea. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Neuracle Science Co., LTD. · Phase 1/2, Interventional, and Treatment
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:
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.
44 studies on the registry are indexed under Hearing Loss, Sudden; 20 are open to participants now.
This study's planned enrollment of 138 is above the median of 68 across 36 interventional studies indexed under Hearing Loss, Sudden.
Browse Hearing Loss, Sudden studies →Neuracle Science Co., LTD. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Part A: healthy volunteers
Part B:
Inclusion Criteria:
Exclusion Criteria:
NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
Biological: NS101 · Biological: Placebo
NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
Biological: NS101 · Biological: Placebo
NS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
Biological: NS101
Placebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
Biological: Placebo
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
Phase 1b part: Change from Baseline in Safety Profiles
Adverse Event, Serious Adverse Event, ratio of Treatment related Serisous Adverse Event with causality \& severity will be descriptively measured and collected in the following time frames
Time frame: Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day43
Phase 2a part: Changes from Baseline in Safety Profiles
Adverse Event, Serious Adverse Event, ratio of Treatment related Serisous Adverse Event with causality \& severity will be descriptively measured and collected in the following time frames
Time frame: Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20
Phase 1b part: Change from Baseline in PK/PD profiles & Immunological Assay
Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve
Time frame: Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day43
Phase 2a part : Change from Baseline in PK/PD profiles & immunological Assay
Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve
Time frame: Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20
Phase 2a part : Change from Baseline in Pure Tone Audiometry, Speech Discrimination Scores and Tinnitus Handicap Inventory in Sudden Sensorineural Hearing Loss Patients
hearing capacity of thresholds (e.g. PTA, ABR, DPOAE, ECochG), speech discrimination (e.g. SRT, SDS) and tinnitus (e.g. THI, VAS)
Time frame: Baseline, Week4, Week8, Week12, Week16, Week20
Plan to share: No — Currently there is no plan to share IPD at this stage
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Neuracle Science Co., LTD.