Age Related Hearing LossNCT07012746
A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss
A study testing TJ0113 capsules in people with Age Related Hearing Loss and Deafness, run by Yilai Shu at 1 site in China.
Trial summary
The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Age Related Hearing Loss, Deafness
- What is being tested?
- TJ0113 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
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
The purpose of this study is to explore the safety and efficacy of TJ0113 capsules in patients with age-related hearing loss.
Read the 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).
- Conditions
- Age Related Hearing Loss, Deafness
- Being tested
- TJ0113 capsules, Placebo capsules
- Medical subject headings
- Presbycusis, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ0113 capsulesDrug
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 .
Placebo capsulesDrug
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 .
| Study group | Role | What they receive |
|---|---|---|
| TJ0113 group | Experimental | Participants will be treated with TJ0113 capsule 200 mg daily for up to 24 weeks Receives: Drug: TJ0113 capsules |
| Placebo group | Placebo comparator | Participants will be treated with a placebo 200 mg daily for up to 24 weeks Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TJ0113 capsule in the treatment of patients with age-related hearing loss
Incidence of adverse events in each group
Measured: Baseline, weeks 1, 4, 12, 24, and 1 week after discontinuation
Secondary outcomes (3)
Speech Intelligibility - Word Recognition in Quiet and Noise
To compare the change in word list-measured recognition accuracy rates for words and short sentences in both quiet and noise.
Measured: From baseline to 4, 12 ,24 weeks
Pure Tone Audiometry (PTA)
To ompare the change in Pure Tone Audiometry (PTA) using the air and bone conduction audiometry for hearing at certain range (Hz).
Measured: From baseline to 4, 12 ,24 weeks
Individual's health-related quality of life (HRQOL)
SF-36 quality of life questionnaire will be measured to compare the change in individual's health-related quality of life using face to face Interview for the scores. Higher scores mean better functioning or fewer symptoms.
Measured: From baseline to 4, 12 ,24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start7 Jun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yilai Shu
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou PhecdaMed Co., Ltd.
- Responsible party
- Sponsor-investigator, Yilai Shu, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012746
- Sponsor's protocol ID
- 2024198-1
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07012746
- Acronym / sponsor ID
- 2024198-1
- Conditions
- Age Related Hearing Loss, Deafness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yilai ShuUniversity, hospital or other
- Collaborators
- Hangzhou PhecdaMed Co., Ltd.
- Study start
- 7 Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TJ0113 group | Experimental | Drug: TJ0113 capsulesParticipants will be treated with TJ0113 capsule 200 mg daily for up to 24 weeks |
| Placebo group | Placebo comparator | Drug: Placebo capsulesParticipants will be treated with a placebo 200 mg daily for up to 24 weeks |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJ0113 capsulesOral 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 | TJ0113 group |
| Placebo capsulesOral 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 group |
Primary outcome
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
Incidence of adverse events in each group
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TJ0113 capsules in people with Age Related Hearing Loss and Deafness, run by Yilai Shu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.