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

Last updated: October 9, 2024
Sponsor: Neuracle Science Co., LTD.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

NS101

Placebo

Clinical Study ID

NCT06249919
NS101_P2_04
  • Ages 19-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Part A: healthy volunteers

Part B:

Inclusion Criteria:

  • unilateral ideopathic SSNHL greater than 55dB at the average of 4 frequencies in PTA (contralateral hearing is less than 30dB)

  • those who started standard treatment within 5 days after symptom onset

  • those who were treated with oral steroids for 14 days, but incomplete recovery wasconfirmed as type III/IV according to Siegel's criteria at the end of the 14-daytreatment

Exclusion

Exclusion Criteria:

  • other otologic or systemic diseases

  • retrocochlear lesion

Study Design

Total Participants: 118
Treatment Group(s): 2
Primary Treatment: NS101
Phase: 1/2
Study Start date:
January 19, 2024
Estimated Completion Date:
June 19, 2025

Connect with a study center

  • SCH University Hospital Bucheon

    Bucheon,
    Korea, Republic of

    Site Not Available

  • Chonam National University Hospital

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Inje University Ilsan Paik Hospital

    Ilsan,
    Korea, Republic of

    Site Not Available

  • Myongji Hospital

    Ilsan,
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Pusan,
    Korea, Republic of

    Site Not Available

  • Hallym Sacred Heart Hospital

    Pyeongchon,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Catholic University Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Yonsei University Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

  • Wonju Severance Christian Hospital

    Wonju,
    Korea, Republic of

    Site Not Available

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