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Recruiting NCT06249919

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

Phase I / Phase II Interventional Seneorineural Deafness Sudden Sensorineural Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NS101, Placebo.
Who it may be relevant to
Registry conditions: Seneorineural Deafness, Sudden Sensorineural Hearing Loss. Basic parameters: 19 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological NS101
    NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
  • Biological Placebo
    Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101

Primary outcome measures

  • Phase 1b part: Change from Baseline in Safety Profiles [Time frame: Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day43]
  • Phase 2a part: Changes from Baseline in Safety Profiles [Time frame: Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20]
Secondary outcome measures (2)
  • Phase 1b part: Change from Baseline in PK/PD profiles & Immunological Assay [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 [Time frame: Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

South Korea · 16 centers
  • SCH University Hospital Bucheon — Bucheon-si
  • Chonam National University Hospital — Gwangju
  • Inje University Ilsan Paik Hospital — Ilsan
  • Myongji Hospital — Ilsan
  • Pusan National University Hospital — Pusan
  • Hallym Sacred Heart Hospital — Pyeongchon
  • Seoul National University Bundang Hospital — Seongnam
  • Asan Medical Center — Seoul
  • … and 8 more centers

Identifiers

NCT: NCT06249919 · NS101_P2_04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗