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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Republic of Korea
SCH University Hospital Bucheon
NOT_YET_RECRUITING
Bucheon-si
Chonam National University Hospital
RECRUITING
Gwangju
Inje University Ilsan Paik Hospital
RECRUITING
Ilsan
Myongji Hospital
NOT_YET_RECRUITING
Ilsan
Pusan National University Hospital
RECRUITING
Pusan
Hallym Sacred Heart Hospital
RECRUITING
Pyeongchon
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Catholic University Seoul St. Mary's Hospital
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Yonsei University Severance Hospital
RECRUITING
Seoul
Ajou University Hospital
NOT_YET_RECRUITING
Suwon
Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Contact Information
Primary
Yunkyung Choi
clinical@neuracles.com
+82269490409
Backup
Suhyun Cho
clinical@neuracles.com
+82269490409
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 138
Treatments
Experimental: Group A
NS101 15mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
Experimental: Group B
NS101 30mg/kg IV infusion Biweekly for 6weeks in Healthy Volunteers (active:placebo=6:3)
Active_comparator: Cohort A
NS101 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
Placebo_comparator: Cohort B
Placebo 15mg/kg IV infusion Biweekly for 12weeks in Sudden Sensorineural Hearing Loss patients
Related Therapeutic Areas
Sponsors
Collaborators: Samsung Medical Center, Severance Hospital, Korea University Anam Hospital
Leads: Neuracle Science Co., LTD.

This content was sourced from clinicaltrials.gov

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