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

Sudden Sensorineural Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249919
• Other study ID #: NS101_P2_04
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 19, 2024
• Est. completion date: June 19, 2025

Study information

• Verified date: January 2024
• Source: Neuracle Science Co., LTD.
• Contact: Yunkyung Choi
• Phone: +82269490409
• Email: clinical[@]neuracles.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: June 19, 2025
• Est. primary completion date: June 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sudden Sensorineural Hearing Loss

Intervention

Biological:
• 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

Locations

Country	Name	City	State
Korea, Republic of	SCH University Hospital Bucheon	Bucheon
Korea, Republic of	Chonam National University Hospital	Gwangju
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Myongji Hospital	Ilsan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Hallym Sacred Heart Hospital	Pyeongchon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (4)

Lead Sponsor	Collaborator
Neuracle Science Co., LTD.	Korea University Anam Hospital, Samsung Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Baseline, Week4, Week8, Week12, Week16, Week20
Primary	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	Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day43
Primary	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	Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20
Secondary	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	Baseline, Day1, Day2, Day3, Day14, Day15, Day16, Day17, Day28, Day29, Day30, Day32, Day43
Secondary	Phase 2b 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	Baseline, Week1, Week2, Week4, Week6, Week8, Week10, Week12, Week16, Week20