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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

January 19, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

January 31, 2027

Conditions
Seneorineural DeafnessSudden Sensorineural Hearing Loss
Interventions
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

Trial Locations (16)

Unknown

NOT_YET_RECRUITING

SCH University Hospital Bucheon, Bucheon-si

RECRUITING

Chonam National University Hospital, Gwangju

RECRUITING

Inje University Ilsan Paik Hospital, Ilsan

NOT_YET_RECRUITING

Myongji Hospital, Ilsan

RECRUITING

Pusan National University Hospital, Pusan

RECRUITING

Hallym Sacred Heart Hospital, Pyeongchon

RECRUITING

Seoul National University Bundang Hospital, Seongnam

RECRUITING

Asan Medical Center, Seoul

RECRUITING

Catholic University Seoul St. Mary's Hospital, Seoul

RECRUITING

Korea University Anam Hospital, Seoul

NOT_YET_RECRUITING

Korea University Anam Hospital, Seoul

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

Yonsei University Severance Hospital, Seoul

NOT_YET_RECRUITING

Ajou University Hospital, Suwon

RECRUITING

Wonju Severance Christian Hospital, Wŏnju

Sponsors
All Listed Sponsors
collaborator

Samsung Medical Center

OTHER

collaborator

Severance Hospital

OTHER

collaborator

Korea University Anam Hospital

OTHER

lead

Neuracle Science Co., LTD.

INDUSTRY

NCT06249919 - A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients | Biotech Hunter | Biotech Hunter