A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss

Official title

A Randomized, Double-Blind, Placebo-Parallel-Controlled Clinical Trial to Explore the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss

Overview

The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss.

Detailed description

The main purpose of this clinical trial is to explore the safety of TJ0113 capsules in patients with age-related hearing loss; the secondary purpose is to explore the effectiveness; and the exploratory purpose is to exploring changes in muscle strength, depression degree, cognition, and biomarkers after TJ0113 capsule treatment in patients with age-related hearing loss. Approximately 60 subjects (aged from 65\~75) will be enrolled in this study according to the randomization and drug randomization tables both of which were generated by computer. The successfully screened subjects were randomly assigned to the 1:1 TJ0113 capsule group (n=30) and placebo group (n=30).

Interventions

• Drug TJ0113 capsules
  Oral intake on an empty stomach in the morning, 200 mg each time, fasting within half an hour after taking. It is recommended to keep the drug at the same time (± 1 h ) of a day .
• Drug Placebo capsules
  Oral intake on an empty stomach in the morning, 200 mg each time, fasting within half an hour after taking. It is recommended to keep the drug at the same time (± 1 h ) of a day .

Primary outcome measures

• Safety of TJ0113 capsule in the treatment of patients with age-related hearing loss [Time frame: Baseline, weeks 1, 4, 12, 24, and 1 week after discontinuation]

Secondary outcome measures (3)

• Speech Intelligibility - Word Recognition in Quiet and Noise [Time frame: From baseline to 4, 12 ,24 weeks]
• Pure Tone Audiometry (PTA) [Time frame: From baseline to 4, 12 ,24 weeks]
• Individual's health-related quality of life (HRQOL) [Time frame: From baseline to 4, 12 ,24 weeks]

Eligibility criteria

Inclusion criteria

• The subjects voluntarily participate in the clinical trial, sign the informed consent form, understand and follow the protocol, and fully understand the test content, process and possible adverse reactions.
• Age between 65 and 80 years (including the critical value)
• A diagnosis of symmetrical sensorineural deafness (SNHL) with a history of> 3 months (binaural threshold difference in mean PTA frequency <15 dB HL), the PTA level should be between moderate (> 35dB) and severe (<80dB) hearing loss
• Hearing aids have not been used, or otherwise, it should be used regularly for more than 3 years and stopped for 3 months before enrollment.
• Subjects and their partners had no birth plan, sperm or egg donation plans from the screening period until within 6 months after the end of the trial and would voluntarily take effective contraception (e. g. abstinence, condoms, etc.). Male subjects should agree to avoid sperm donation within 6 months from the start of administration until cessation of study treatment. Female subjects should be menopausal (over 24 months).

Exclusion criteria

• The presence of implants in the study ear (such as cochlear implant, artificial hearing bone, etc.);
• Suffering from acute otitis media or other ear infection within the previous 3 months or previous chronic suppurative otitis media or tympanic membrane perforation, or with conductive deafness, previous history of ear trauma or surgery, combined middle ear or inner ear malformation, otosclerosis, Meniere's disease, sudden deafness and no recovery of hearing, all of which will impact results explained.
• Patients with sensorineural deafness caused by non-aging factors (e. g., hereditary deafness, congenital deafness, drug-induced deafness, noise deafness, neurosyphilis, severe retrocochlear lesions or organic lesions), and unilateral deafness
• Occupation that is sensitive to sound: musician, conductor, music teacher, etc.
• Use headphones at high volume or frequent exposure to noise in previous work or life;
• History of alcohol or drug dependence / drug abuse in the last 1 year;
• Positive pregnancy test at screening or at the baseline visit, pregnant, lactating, or planned to become pregnant during the trial

7.Failure to swallow oral medication, or, according to the investigator, any conditions that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or that may pose a hazard to the subjects participating in this trial; 9.People who currently taking drugs that can improve symptoms such as dementia and depression 10.Subjects with a severe or unstable systemic disease, such as serious congenital disease, blood disease, endocrine disease, nerve or nervous system disease, end-stage disease, head and neck tumor radiotherapy and chemotherapy history, major surgical treatment, psychological disorders (severe insomnia, severe depression, severe anxiety, etc. diagnosed within the previous 90 days ) or history and clinical significance of abnormal baseline laboratory values, such as hepatic insufficiency (alanine transaminase (ALT) and / or alanine transaminase (AST) is 2 times above the upper limit of the reference range, or renal insufficiency (creatinine clearance Ccr <30 mL/min), or history of malignant tumors and the detection results of tumor markers during the screening period have clinical significance, or unsuitable participants, as judged by the investigator; 11.Subjects suffering from any one of the following heart diseases: a. having uncontrolled or serious cardiovascular and cerebrovascular disease, including the development of grade II ( New York Heart Association, NYHA) or above congestive heart failure, unstable angina, acute myocardial infarction within 6 months before the first drug administration, or cardiac arrhythmias requiring treatment at screening; With b. hypertension (systolic pressure≥ 160mmHg and / or diastolic v≥ 100mmHg), and after the combination of two or more antihypertensive drugs can not be reduced to the normal range; or c.with a history of clinically significant ECG abnormalities, the QRS time was> 120ms, Long QT syndrome: QTc interval> 450ms in male or QTc interval> 470ms in female.

12.Participated in a clinical study involving the administration, device, or surgery of the study drug (new chemical entity) within 90 days or 5 half-lives (whichever is longer) 13.Patients with a previous history of hepatitis B, or any of the following indicators are positive at screening: hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody.

14.The subject is not fit to participate in the study if the investigator considers. Or the subject could not participate in the trial for his own reasons, or the behavior subject may interfere with treatment, study or interpretation of results (e. g., previous treatment with high-dose aminoglycosides).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Eye & ENT Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07012746 · 2024198-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗