A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
- Conditions
- Seneorineural DeafnessSudden Sensorineural Hearing Loss
- Interventions
- Biological: Placebo
- Registration Number
- NCT06249919
- Lead Sponsor
- Neuracle Science Co., LTD.
- 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 available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 118
- 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
- other otologic or systemic diseases
- retrocochlear lesion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Placebo NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3) Group A Placebo NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3) Group A NS101 NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3) Cohort B Placebo Placebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients Cohort A NS101 NS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients Group B NS101 NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
- Primary Outcome Measures
Name Time Method Phase 1b part: Change from Baseline in Safety Profiles 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 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
Name Time Method 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 Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve
Phase 2a part : Change from Baseline in PK/PD profiles & immunological Assay 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
Trial Locations
- Locations (15)
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of
SCH University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Chonam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Myongji Hospital
🇰🇷Ilsan, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym Sacred Heart Hospital
🇰🇷Pyeongchon, Korea, Republic of
Catholic University Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of