Actively Recruiting
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
Led by Neuracle Science Co., LTD. · Updated on 2025-08-13
138
Participants Needed
16
Research Sites
158 weeks
Total Duration
On this page
Sponsors
N
Neuracle Science Co., LTD.
Lead Sponsor
S
Samsung Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 19 to 70 years
- Patients with unilateral idiopathic sudden sensorineural hearing loss greater than 45 dB at the average of 4 frequencies in pure tone audiometry
- Contralateral ear hearing less than 30 dB
- Patients who completed investigator-recognized standard treatment within 30 days of symptom onset
- Patients able to undergo randomization visit within 35 days of symptom onset
- Patients who have received approximately 2 weeks of systemic steroid therapy with sufficient recovery time
- Patients treated with a combination of approximately 2 weeks of systemic steroid therapy and intratympanic steroid administration
You will not qualify if you...
- Patients with other otologic or systemic diseases
- Patients with retrocochlear lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
SCH University Hospital Bucheon
Bucheon-si, South Korea
Not Yet Recruiting
2
Chonam National University Hospital
Gwangju, South Korea
Actively Recruiting
3
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Actively Recruiting
4
Myongji Hospital
Ilsan, South Korea
Not Yet Recruiting
5
Pusan National University Hospital
Pusan, South Korea
Actively Recruiting
6
Hallym Sacred Heart Hospital
Pyeongchon, South Korea
Actively Recruiting
7
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
8
Asan Medical Center
Seoul, South Korea
Actively Recruiting
9
Catholic University Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
10
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
11
Korea University Anam Hospital
Seoul, South Korea
Not Yet Recruiting
12
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
13
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
14
Yonsei University Severance Hospital
Seoul, South Korea
Actively Recruiting
15
Ajou University Hospital
Suwon, South Korea
Not Yet Recruiting
16
Wonju Severance Christian Hospital
Wŏnju, South Korea
Actively Recruiting
Research Team
Y
Yunkyung Choi
CONTACT
S
Suhyun Cho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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