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A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06249919
Recruitment Status : Recruiting
First Posted : February 8, 2024
Last Update Posted : February 8, 2024
Sponsor:
Collaborators:
Severance Hospital
Samsung Medical Center
Korea University Anam Hospital
Information provided by (Responsible Party):
Neuracle Science Co., LTD.

Study Description
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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.

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.


Condition or disease Intervention/treatment Phase
Seneorineural Deafness Sudden Sensorineural Hearing Loss Biological: NS101 Biological: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 19, 2024
Estimated Primary Completion Date : June 19, 2025
Estimated Study Completion Date : June 19, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
 Biological: NS101
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases

Biological: Placebo
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
Experimental: Group B
NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
 Biological: NS101
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases

Biological: Placebo
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
Active Comparator: Cohort A
NS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
 Biological: NS101
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Placebo Comparator: Cohort B
Placebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
 Biological: Placebo
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve

  2. Phase 2b part : Change from Baseline in PK/PD profiles & immunological Assay [ Time Frame: Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20 ]
    Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve


Other Outcome Measures:
  1. Phase 2a part : Change from Baseline in Pure Tone Audiometry, Speech Discrimination Scores and Tinnitus Handicap Inventory in Sudden Sensorineural Hearing Loss Patients [ Time Frame: Baseline, Week4, Week8, Week12, Week16, Week20 ]
    hearing capacity of thresholds (e.g. PTA, ABR, DPOAE, ECochG), speech discrimination (e.g. SRT, SDS) and tinnitus (e.g. THI, VAS)


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Part A: healthy volunteers

Part B:

Inclusion Criteria:

  • unilateral ideopathic SSNHL greater than 55dB at the average of 4 frequencies in PTA (contralateral hearing is less than 30dB)
  • those who started standard treatment within 5 days after symptom onset
  • those who were treated with oral steroids for 14 days, but incomplete recovery was confirmed as type III/IV according to Siegel's criteria at the end of the 14-day treatment

Exclusion Criteria:

  • other otologic or systemic diseases
  • retrocochlear lesion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06249919


Contacts
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Contact: Yunkyung Choi +82269490409 clinical@neuracles.com
Contact: Suhyun Cho +82269490409 clinical@neuracles.com

Locations
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Korea, Republic of
SCH University Hospital Bucheon Not yet recruiting
Bucheon, Korea, Republic of
Contact: JD Lee, MD/PhD         
Chonam National University Hospital Not yet recruiting
Gwangju, Korea, Republic of
Contact: HH Cho, MD/PhD         
Inje University Ilsan Paik Hospital Not yet recruiting
Ilsan, Korea, Republic of
Contact: JM Lee, MD/PhD         
Myongji Hospital Not yet recruiting
Ilsan, Korea, Republic of
Contact: DB Sim, MD/PhD         
Pusan National University Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: SG Kong, MD/PhD         
Hallym Sacred Heart Hospital Not yet recruiting
Pyeongchon, Korea, Republic of
Contact: HJ Lee, MD/PhD         
Seoul National University Bundang Hospital Not yet recruiting
Seongnam, Korea, Republic of
Contact: JJ Song, MD/PhD         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: HJ Park, MD/PhD         
Catholic University Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: SN Park, MD/PhD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: JY Park, MD/PhD         
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: GJ Im, MD/PhD         
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: IJ Moon, MD/PhD         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: MH Seo, MD/PhD         
Yonsei University Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: JY Choi, MD/PhD         
Ajou University Hospital Not yet recruiting
Suwon, Korea, Republic of
Contact: YH Jeong, MD/PhD         
Wonju Severance Christian Hospital Not yet recruiting
Wonju, Korea, Republic of
Contact: YJ Seo, MD/PhD         
Sponsors and Collaborators
Neuracle Science Co., LTD.
Severance Hospital
Samsung Medical Center
Korea University Anam Hospital
Investigators
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Study Director: Joseph Park, M.D. Neuracle Science
More Information
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Responsible Party: Neuracle Science Co., LTD.
ClinicalTrials.gov Identifier: NCT06249919    
Other Study ID Numbers: NS101_P2_04
First Posted: February 8, 2024    Key Record Dates
Last Update Posted: February 8, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently there is no plan to share IPD at this stage

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neuracle Science Co., LTD.:
Sensorineural disease
sudden sensorineural hearing loss
sensorineural hearing loss
 sudden deafness
cochlear synaptopathy
hidden auditory synaptopathy
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases