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

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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.

Tracking Information
First Submitted Date  ICMJE January 12, 2024
First Posted Date  ICMJE February 8, 2024
Last Update Posted Date February 8, 2024
Actual Study Start Date  ICMJE January 19, 2024
Estimated Primary Completion Date June 19, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2024)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2024)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2024)		 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Seneorineural Deafness
  • Sudden Sensorineural Hearing Loss
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Group A
    NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
    Interventions:
    • Biological: NS101
    • Biological: Placebo
  • Experimental: Group B
    NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
    Interventions:
    • Biological: NS101
    • Biological: Placebo
  • Active Comparator: Cohort A
    NS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
    Intervention: Biological: NS101
  • Placebo Comparator: Cohort B
    Placebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2024)		 118
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 19, 2025
Estimated Primary Completion Date June 19, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yunkyung Choi +82269490409 clinical@neuracles.com
Contact: Suhyun Cho +82269490409 clinical@neuracles.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06249919
Other Study ID Numbers  ICMJE NS101_P2_04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Currently there is no plan to share IPD at this stage
Current Responsible Party Neuracle Science Co., LTD.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Neuracle Science Co., LTD.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Severance Hospital
  • Samsung Medical Center
  • Korea University Anam Hospital
Investigators  ICMJE
Study Director: Joseph Park, M.D. Neuracle Science
PRS Account Neuracle Science Co., LTD.
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP