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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• 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

Trial sites (16)