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Tests treatment safety and results for Seneorineural Deafness
Official title A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
ClinicalTrials.gov ID: NCT06249919
What this study is testing
What is NS101?
NS101 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for seneorineural deafness.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Part A: healthy volunteers Part B:
- 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...
- people 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
You likely can't join if
- other otologic or systemic diseases
- retrocochlear lesion
The study team makes the final eligibility decision.
Where it's taking place
- Bucheon-si, South Korea
- Gwangju, South Korea
- Ilsan, South Korea
- Pusan, South Korea
- Pyeongchon, South Korea
- Seongnam, South Korea
- Seoul, South Korea
- Suwon, South Korea
- Wŏnju, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bucheon-si, South Korea; Gwangju, South Korea; Ilsan, South Korea; Pusan, South Korea; Pyeongchon, South Korea; Seongnam, South Korea and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.