A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
Key facts
- Who runs it
- Neuracle Science Co., LTD.
- Where
- South Korea15 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 1/2
- People taking part
- 113 people enrolled
- Started
- 15 Feb 2024
- Ended
- 4 May 2026
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- NS101
- Placebo
- Record updated
- 2 November 2026
Who can take part
- Age
- 19 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- unilateral idiopathic 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
Who cannot take part
- other otologic or systemic diseases
- retrocochlear lesion
Other criteria
- Part A: healthy volunteers
- Part B:
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- Group ATreatment being tested
Part A: NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
Treatment: NS101 and Placebo
- Group BTreatment being tested
Part A: NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
Treatment: NS101 and Placebo
- Cohort ATreatment being tested
Part B : NS101 15mg/kg IV infusion once a week for 2 weeks as a loading dose, and then at 2-week intervals for 10 weeks in Sudden Sensorineural Hearing Loss patients (active:placebo=1:1 ratio)
Treatment: NS101
- Cohort BPlacebo, for comparison
Part B : Placebo 15mg/kg IV infusion once a week for 2 weeks as a loading dose, and then at 2-week intervals for 10 weeks in Sudden Sensorineural Hearing Loss patients (active:placebo=1:1 ratio)
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1b/2a, Prospective, Randomized, Double-blinded, Placebo-controlled, Multiple Doses, Multicenter, Two Step-up, Exploratory Study Evaluating the Safety, Tolerability, PK/PD and Efficacy of Systemic NS101 in Healthy Volunteer and Patients With Sudden Sensorineural Hearing Loss
- Record updated
- 2 November 2026