A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
Recruiting
Phase 1
Phase 2
Interventional Study
Seneorineural Deafness
Sudden Sensorineural Hearing Loss
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 19 – 70
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 138 (estimated)
- Sponsor
- Neuracle Science Co., LTD. · Industry
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About This Trial
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 dose…
Trial Locations
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Eligibility Criteria
Part A: healthy volunteers
Part B:
Inclusion Criteria:
* 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 abl…
Contacts