Seneorineural DeafnessPhase 1/2NCT06249919
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
A Phase 1/2 study testing NS101 in people with Seneorineural Deafness and Sudden Sensorineural Hearing Loss, run by Neuracle Science Co., LTD. at 16 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Seneorineural Deafness, Sudden Sensorineural Hearing Loss
- What is being tested?
- NS101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 19 Jan 2024to 31 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other otologic or systemic diseases
- retrocochlear lesion
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
South Korea16 sites, 16 recruiting
- Not yet recruiting
SCH University Hospital Bucheon
Bucheon-si
JD Lee, MD/PhD
- Recruiting
Chonam National University Hospital
Gwangju
HH Cho, MD/PhD
- Recruiting
Inje University Ilsan Paik Hospital
Ilsan
JM Lee, MD/PhD
- Not yet recruiting
Myongji Hospital
Ilsan
DB Sim, MD/PhD
- Recruiting
Pusan National University Hospital
Pusan
SG Kong, MD/PhD
- Recruiting
Hallym Sacred Heart Hospital
Pyeongchon
HJ Lee, MD/PhD
- Recruiting
Seoul National University Bundang Hospital
Seongnam
JJ Song, MD/PhD
- Recruiting
Asan Medical Center
Seoul
HJ Park, MD/PhD
- Recruiting
Catholic University Seoul St. Mary's Hospital
Seoul
SN Park, MD/PhD
- Recruiting
Korea University Anam Hospital
Seoul
JY Park, MD/PhD
- Not yet recruiting
Korea University Anam Hospital
Seoul
GJ Im, MD/PhD
- Recruiting
Samsung Medical Center
Seoul
IJ Moon, MD/PhD
- Recruiting
Seoul National University Hospital
Seoul
MH Seo, MD/PhD
- Recruiting
Yonsei University Severance Hospital
Seoul
JY Choi, MD/PhD
- Not yet recruiting
Ajou University Hospital
Suwon
YH Jeong, MD/PhD
- Recruiting
Wonju Severance Christian Hospital
Wŏnju
YJ Seo, MD/PhD
About this study
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
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:
Read more
- 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.
- Being tested
- NS101, Placebo
- Keywords
- Sensorineural disease, sudden sensorineural hearing loss, sensorineural hearing loss, sudden deafness, cochlear synaptopathy, hidden auditory synaptopathy
- Medical subject headings
- Hearing Loss, Sudden, Hearing Loss, Sensorineural, Hearing Loss, Hidden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS101Biological
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
PlaceboBiological
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3) Receives: Biological: NS101; Biological: Placebo |
| Group B | Experimental | NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3) Receives: Biological: NS101; Biological: Placebo |
| Cohort A | Active comparator | NS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients Receives: Biological: NS101 |
| Cohort B | Placebo comparator | Placebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b part: Change from Baseline in Safety Profiles
Adverse Event, Serious Adverse Event, ratio of Treatment related Serisous Adverse Event with causality \& severity will be descriptively measured and collected in the following time frames
Measured: Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day43
Phase 2a part: Changes from Baseline in Safety Profiles
Adverse Event, Serious Adverse Event, ratio of Treatment related Serisous Adverse Event with causality \& severity will be descriptively measured and collected in the following time frames
Measured: Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20
Secondary outcomes (2)
Phase 1b part: Change from Baseline in PK/PD profiles & Immunological Assay
Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve
Measured: 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
Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve
Measured: Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start19 Jan 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seneorineural DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 1b/2a, prospective, randomized, double-blind, placebo-controlled, multicenter, dose-escalation, exploratory study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and efficacy of multiple doses of NS101 in healthy adults and patients with sudden Sensorineural Hearing Loss
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuracle Science Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Samsung Medical Center, Severance Hospital, Korea University Anam Hospital
- Responsible party
- Sponsor
- Investigators
- Joseph Park, M.D., Study director, Neuracle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249919
- Sponsor's protocol ID
- NS101_P2_04
- Status last verified
- Aug 2025
- First submitted
- 12 Jan 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there is no plan to share IPD at this stage
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06249919
- Acronym / sponsor ID
- NS101_P2_04
- Keywords
- Sensorineural disease, sudden sensorineural hearing loss, sensorineural hearing loss, sudden deafness, cochlear synaptopathy, hidden auditory synaptopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Neuracle Science Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Samsung Medical Center, Severance Hospital, Korea University Anam Hospital
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A Phase 1b/2a, prospective, randomized, double-blind, placebo-controlled, multicenter, dose-escalation, exploratory study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and efficacy of multiple doses of NS101 in healthy adults and patients with sudden Sensorineural Hearing Loss
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: NS101, Biological: PlaceboNS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3) |
| Group B | Experimental | Biological: NS101, Biological: PlaceboNS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3) |
| Cohort A | Active comparator | Biological: NS101NS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients |
| Cohort B | Placebo comparator | Biological: PlaceboPlacebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- other otologic or systemic diseases
- retrocochlear lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS101NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases | Biological | Cohort A, Group A, Group B |
| PlaceboPlacebo (i.e. fake drug without active pharmaceutical ingredient) of NS101 | Biological | Cohort B, Group A, Group B |
Primary outcome
Phase 1b part: Change from Baseline in Safety Profiles
Time frame: Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day43
Adverse Event, Serious Adverse Event, ratio of Treatment related Serisous Adverse Event with causality \& severity will be descriptively measured and collected in the following time frames
Phase 2a part: Changes from Baseline in Safety Profiles
Time frame: Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20
Adverse Event, Serious Adverse Event, ratio of Treatment related Serisous Adverse Event with causality \& severity will be descriptively measured and collected in the following time frames
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No. Currently there is no plan to share IPD at this stage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Park, M.D. study director
Neuracle Science
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NS101 in people with Seneorineural Deafness and Sudden Sensorineural Hearing Loss, run by Neuracle Science Co., LTD. at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunkyung Choi (+82269490409, clinical@neuracles.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b part: Change from Baseline in Safety Profiles (time frame: Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day43). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.