None listed
Conditions
Interventions
Drug : The investigational product used in this clinical trial is WK0202 Capsule 100 mg, which contains orange granules filled in an opaque dark-brown oblong hard capsule. The corresponding control pr
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 45 to 70 years at the time of providing written informed consent. 2) Patients with bilateral age-related sensorineural hearing loss (SNHL) that cannot be explained by factors other than aging: Hearing threshold between 40 dB and 70 dB, calculated using the 6-frequency method (average of 0.5, 1, 2, and 4 kHz). 3) Female subjects or male subjects with a female partner who agree to maintain the following contraceptive methods during the trial period: ? The female subject or the female partner of a male subject is postmenopausal (at least 12 months of non-therapy-induced amenorrhea). ? The female subject or the female partner of a male subject is surgically sterile (absence of ovaries and/or uterus). ? Subjects who agree to absolute abstinence during the clinical trial. (For female subjects, periodic abstinence—e.g., rhythm, ovulation, symptothermal, or post-ovulation methods—and withdrawal are not considered acceptable forms of abstinence). ? If the female subject or the female partner of a male subject is a Woman of Childbearing Potential (WOCBP), they must agree to use the following methods: • For both: Intrauterine device (IUD), tubal ligation/surgical sterilization, or condom/diaphragm combined with spermicide. • For male subjects: Condom combined with spermicide. [Note: Oral or subdermal hormonal contraceptives are not recognized methods for this trial. However, their use by the spouse or partner of a male subject is permitted.] 4) Subjects who, after receiving and fully understanding a sufficient explanation of the trial, voluntarily decide to participate and provide written informed consent to comply with the requirements. 5) Subjects deemed eligible by the investigator based on physical examination, laboratory tests, and medical history.
Exclusion criteria
Exclusion criteria: 1)Otological Conditions: Presence of any otological disorders as determined by the investigator, including but not limited to: conductive hearing loss, mixed hearing loss, or acute sensorineural hearing loss (SNHL); fluctuating hearing in both ears; bilateral acute SNHL; prior or recurrent unilateral acute SNHL; Meniere’s disease; autoimmune hearing loss; radiation-induced hearing loss; Sensorineural hearing loss secondary to endolymphatic hydrops; ototoxicity-induced hearing loss; chronic granulomatous or suppurative otitis media; and unilateral SNHL. 2) Systemic and Neurological Conditions: Presence of diabetes mellitus; systemic fungal infection within the last 6 months; other major cardiovascular or oncological diseases within the last 6 months; neuropsychiatric disorders including epilepsy, autism spectrum disorder, or schizophrenia; neurological disorders such as stroke, transient ischemic attack (TIA), or any loss of consciousness or motor function within the last 6 months; or any clinically significant systemic disease or infection within the last 30 days. Additionally, those with persistent thyroid dysfunction or any condition that, in the investigator’s judgment, would interfere with the subject’s appropriate participation in the trial. 3) Hypersensitivity: Known hypersensitivity or history of clinically significant hypersensitivity to WK0202, drugs in the same class, capsule excipients, or other medications (e.g., aspirin, antibiotics, etc.). 4) Prior Clinical Trial Participation: Participation in any other clinical trial for investigational drugs or medical devices within the last 6 months. 5)Investigator's Discretion: Any subject deemed unsuitable for participation in the study based on the investigator’s clinical judgment. 6)Infectious Diseases: Positive results in immunochemical screening tests (HIV, HBsAg, anti-HCV). 7)Pregnancy and Lactation: Women who are pregnant or breastfeeding. 8)Laboratory Abnormalities: Clinically significant abnormalities in laboratory test results. 9)Substance Abuse: Current abuse or history of drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Pure Tone Audiometry (PTA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Pure Tone Audiometry (PTA);Changes in Distortion Product Otoacoustic Emissions (DPOAE);Changes in Auditory Brainstem Response (ABR);The change in speech reception threshold (SRT);Changes in Speech Discrimination Score (SDS) / Word Recognition Score (WRS);The change in Tinnitus Handicap Inventory (K-THI);Changes in Tactile Visual Analog Scale (T-VAS);Changes in Tinnitogram loudness ;Safety assessment – adverse events, vital signs, and laboratory tests | — |
Countries
Korea, Republic of
Contacts
Public ContactJungho Ha
Ajou University Hospital
Outcome results
None listed