A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
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
1 other identifier
interventional
138
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2024
Typical duration for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2024
CompletedStudy Start
First participant enrolled
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
August 13, 2025
August 1, 2025
2.4 years
January 12, 2024
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
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
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
Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20
Other Outcomes (1)
Phase 2a part : Change from Baseline in Pure Tone Audiometry, Speech Discrimination Scores and Tinnitus Handicap Inventory in Sudden Sensorineural Hearing Loss Patients
Baseline, Week4, Week8, Week12, Week16, Week20
Study Arms (4)
Group A
EXPERIMENTALNS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
Group B
EXPERIMENTALNS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
Cohort A
ACTIVE COMPARATORNS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
Cohort B
PLACEBO COMPARATORPlacebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- other otologic or systemic diseases
- retrocochlear lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuracle Science Co., LTD.lead
- Samsung Medical Centercollaborator
- Severance Hospitalcollaborator
- Korea University Anam Hospitalcollaborator
Study Sites (16)
SCH University Hospital Bucheon
Bucheon-si, South Korea
Chonam National University Hospital
Gwangju, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Myongji Hospital
Ilsan, South Korea
Pusan National University Hospital
Pusan, South Korea
Hallym Sacred Heart Hospital
Pyeongchon, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Catholic University Seoul St. Mary's Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joseph Park, M.D.
Neuracle Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2024
First Posted
February 8, 2024
Study Start
January 19, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Currently there is no plan to share IPD at this stage