A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19-70
SponsorNeuracle Science Co., LTD.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
other otologic or systemic diseases
retrocochlear lesion
Trial design
Design model
Parallel
Treatments tested in this trial
NS101
Biological/VaccineNS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Placebo
Biological/VaccinePlacebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
Treatment groups
138 Participants
are divided into 4 treatment groupsGroup A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Group C: Cohort AActive comparator 1 intervention
Group D: Cohort BPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day432
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
Time frame
Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20Secondary outcomes
1
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
Time frame
Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day432
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
Time frame
Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20Other 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
hearing capacity of thresholds (e.g. PTA, ABR, DPOAE, ECochG), speech discrimination (e.g. SRT, SDS) and tinnitus (e.g. THI, VAS)
Time frame
Baseline, Week4, Week8, Week12, Week16, Week20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Neuracle Science Co., LTD.
Lead sponsor
Samsung Medical Center
Collaborator
Severance Hospital
Collaborator
Korea University Anam Hospital
Collaborator
Source ClinicalTrials.gov