A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
Launched by NEURACLE SCIENCE CO., LTD. · Jan 31, 2024
Trial Information
Current as of November 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment called NS101 for people who have sudden sensorineural hearing loss (SSNHL), which is a type of hearing loss that can happen suddenly and often affects one ear. The study aims to find out if NS101 is safe to take, how well it works, and if it can help restore hearing in patients who haven’t improved enough with standard steroid treatment. The trial involves healthy volunteers and SSNHL patients, who will receive either NS101 or a placebo (a fake treatment) for less than three months.
To participate, healthy volunteers must be between 18 and 75 years old, while SSNHL patients need to have a significant hearing loss and must have started treatment within five days of their symptoms appearing. They should also have received oral steroids for 14 days but not experienced enough recovery. Participants can expect to either receive the active treatment or the placebo and will be monitored closely throughout the study to ensure their safety. This trial is currently recruiting participants of all genders to help us learn more about this potential new therapy.
Gender
ALL
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 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
- Exclusion Criteria:
- • other otologic or systemic diseases
- • retrocochlear lesion
About Neuracle Science Co., Ltd.
Neuracle Science Co., Ltd. is a pioneering clinical research organization dedicated to advancing neurological health through innovative therapeutic solutions. With a strong commitment to scientific excellence, Neuracle focuses on the development and commercialization of cutting-edge technologies aimed at diagnosing and treating neurological disorders. The company leverages a multidisciplinary approach, collaborating with leading researchers and healthcare professionals to drive clinical trials that yield impactful results. Neuracle's mission is to enhance patient outcomes and improve quality of life by translating groundbreaking research into effective treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seongnam, Korea, Republic Of
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Suwon, Korea, Republic Of
Pusan, Korea, Republic Of
Seoul, Korea, Republic Of
Ilsan, Korea, Republic Of
Seoul, Korea, Republic Of
Wonju, Korea, Republic Of
Wonju, Gangwon Do, Korea, Republic Of
Seoul, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Bucheon, Korea, Republic Of
Gwangju, Korea, Republic Of
Ilsan, Korea, Republic Of
Pyeongchon, Korea, Republic Of
Patients applied
Trial Officials
Joseph Park, M.D.
Study Director
Neuracle Science
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported