A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
NCT ID: NCT06249919
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
138 participants
INTERVENTIONAL
2024-01-19
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
NS101
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Placebo
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
Group B
NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
NS101
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Placebo
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
Cohort A
NS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
NS101
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Cohort B
Placebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
Placebo
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
Interventions
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NS101
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Placebo
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* retrocochlear lesion
19 Years
70 Years
ALL
Yes
Sponsors
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Samsung Medical Center
OTHER
Severance Hospital
OTHER
Korea University Anam Hospital
OTHER
Neuracle Science Co., LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Park, M.D.
Role: STUDY_DIRECTOR
Neuracle Science
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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JD Lee, MD/PhD
Role: primary
HH Cho, MD/PhD
Role: primary
JM Lee, MD/PhD
Role: primary
DB Sim, MD/PhD
Role: primary
SG Kong, MD/PhD
Role: primary
HJ Lee, MD/PhD
Role: primary
JJ Song, MD/PhD
Role: primary
HJ Park, MD/PhD
Role: primary
SN Park, MD/PhD
Role: primary
JY Park, MD/PhD
Role: primary
GJ Im, MD/PhD
Role: primary
IJ Moon, MD/PhD
Role: primary
MH Seo, MD/PhD
Role: primary
JY Choi, MD/PhD
Role: primary
YH Jeong, MD/PhD
Role: primary
YJ Seo, MD/PhD
Role: primary
Other Identifiers
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NS101_P2_04
Identifier Type: -
Identifier Source: org_study_id
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