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

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Description

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:

whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of NS101 against FAM19A5
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.

Study Overview

Start Date
January 19, 2024
Completion Date
June 19, 2025
Enrollment
118
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Korea University Anam Hospital
Seoul, Korea, Republic of

Eligibility

Minimum Age (years)
19
Maximum Age (years)
65
Eligibility Criteria
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 was confirmed as type III/IV according to Siegel's criteria at the end of the 14-day treatment

Exclusion Criteria:

other otologic or systemic diseases
retrocochlear lesion

Study Contact Info

Study Contact Name
Yunkyung Choi; Suhyun Cho
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06249919