Sudden Sensorineural Hearing LossPhase 1NCT04961099
Phase I Clinical Study of HY01 in Patients
A Phase 1 study testing HY01 in people with Sudden Sensorineural Hearing Loss, run by Heyu (Suzhou) Pharmaceutical Technology Co., Ltd at 1 site in China.
Trial summary
Phase I clinical study on the safety, tolerance, efficacy and pharmacokinetics of repeated intratympanic HY01 in patients with sudden sensorineural hearing loss. In this study, low-dose group and high-dose group were designed, 6 cases in each group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sudden Sensorineural Hearing Loss
- What is being tested?
- HY01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2021to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese subjects were 18-65 years old (including boundary value), male and female were not limited;
- Patients with unilateral sudden deafness;
- At least 7 days after the last medication (according to the guidelines for diagnosis and treatment of sudden deafness, the drugs allowed to be used include glucocorticoids, batroxobin, neurotrophic drugs (such as Mecobalamin, neurotrophic factors, etc.), antioxidants (such as lipoic acid, Ginkgo biloba extract, etc.) and lidocaine) ;
- The hearing recovery of patients with sudden deafness after initial treatment is less than 15dB or less than 50% of the hearing of the affected ear or the healthy ear before the onset of the disease ;
- 19≤BMI<26kg/m2；
- After at least one course of standard treatment (according to the guidelines for diagnosis and treatment of sudden deafness, systemic hormone combined with other drugs) ;
- The informed consent was signed before the trial, and the trial content, process and possible adverse reactions were fully understood.
Who cannot join
- Ear diseases
- Patients with bilateral sudden deafness;
- The initial treatment was intratympanic glucocorticoid;
- The average hearing threshold of healthy ear was more than 25 dB;
- Patients with previous or current ear related diseases may affect the judgment of adverse events, including but not limited to chronic ear infection, cholesteatoma, Meniere's disease, otosclerosis, fluctuating hearing loss, acoustic trauma, autoimmune hearing loss, radiation-induced hearing loss, syphilitic deafness, endolymphatic hydrops, hearing loss caused by otological surgery Suspected retrocochlear lesions, suspected perilymph fistula or membrane rupture, perilymph fistula or barotrauma, acoustic neuroma, synchronous tinnitus (possibly caused by glomus jugulare tumor), skull, face or temporal bone abnormalities;
- Subjects with congenital deafness and hereditary deafness;
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- Treatment history of ototoxicity drugs within 6 months, such as chemotherapy, loop diuretics, aminoglycosides, quinine, high-dose aspirin, etc;
- Subjects considered unsuitable for this clinical study.
- Systemic diseases
- Previous or current contraindications to glucocorticoids include hypertension, thrombosis, myocardial infarction, gastric and duodenal ulcer, visceral surgery, psychosis, electrolyte metabolism abnormality, glaucoma;
- Previous or current patients with glucocorticoid caution include infection, ulcerative colitis, diverticulitis, postoperative enterostomy, liver cirrhosis, renal dysfunction, epilepsy, migraine, myasthenia gravis, osteoporosis, hypothyroidism, ocular herpes simplex, chickenpox or measles, recent live attenuated vaccine, latent tuberculosis or old tuberculosis Hepatitis B virus carriers;
- Corticosteroid related psychiatric reactions;
- It is forbidden to use this product for allergic patients, and it should be used with caution for subjects with allergic history to adrenocortical hormone drugs;
- Subjects with positive TB history or tuberculin test (PPD);
- Type 1 and type 2 diabetes;
- pancreatitis;
- Suffering from rheumatic diseases, such as rheumatoid arthritis, scleroderma, lupus, etc;
- Previous or current use of chemotherapy or immunosuppressive drugs;
- Active herpes zoster;
- Those who had taken any medicine other than sudden deafness within 14 days before the first administration;
- There was a history of alcohol abuse and drug abuse in one year before screening;
- Those who had participated in any clinical trial within 3 months before the first administration of the trial;
- Blood donation or blood loss ≥ 200ml within 3 months before the first administration;
- Those who do not agree to avoid using alcohol, tobacco or caffeinated drinks within 24 hours before and during the trial, or to avoid strenuous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism and excretion;
- Pregnant or lactating women, or those whose plasma hCG test was positive, or those who could not or did not take contraceptive measures approved by the researcher within 6 months from the study period to the end of the study according to the guidance of the researcher;
- Serological tests or other tests showed that subjects with positive hepatitis B, HCV, syphilis and AIDS were positive.
- Subjects considered unsuitable for this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200940
Ding Xueying, Doctor, 86 021-36123569, dingxueying@126.com
About this study
Official title: Phase I Clinical Study on the Safety, Tolerance, Efficacy and Pharmacokinetics of Repeated Intratympanic HY01 in Patients With Sudden Sensorineural Hearing Loss
Phase I clinical study on the safety, tolerance, efficacy and pharmacokinetics of repeated intratympanic HY01 in patients with sudden sensorineural hearing loss. In this study, low-dose group and high-dose group were designed, 6 cases in each group.
Read the detailed description
The incidence rate of sudden deafness is increasing year by year, which can cause severe hearing loss. Intratympanic HY01 can increase the local drug concentration in the ear, which is equal to or better than that in the treatment of sudden sensorineural hearing loss, and reduce the systemic drug concentration at the same time. It has obvious clinical value for the treatment of hormone forbidden population.
HY01 is one of glucocorticoid drugs. In this study, we designed low-dose group and high-dose group of HY01, and enrolled 6 patients with sudden sensorineural hearing loss for salvage therapy in each group. HY01 will be administrated on D1, D4 and D7 . The trial will be ended 30 days after the first administration.
After determining the safety of low-dose, the patients in the high-dose group will be enrolled. The safety observation indexes included systemic Routine Indexes and otology indexes, and the efficacy and pharmacokinetics were observed at the same time.
- Conditions
- Sudden Sensorineural Hearing Loss
- Being tested
- HY01
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HY01Drug
low-dose group: HY01 10mg（20mg/ml）, administrated on D1, D4 and D7 high-dose group: HY01 20mg（40mg/ml）, administrated on D1, D4 and D7
| Study group | Role | What they receive |
|---|---|---|
| low-dose group | Experimental | low-dose group: HY01 10mg（20mg/ml） Receives: Drug: HY01 |
| high-dose group | Experimental | high-dose group: HY01 20mg（40mg/ml） Receives: Drug: HY01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of HY01
AEs and SAEs
Measured: Throughout the study approximately 30 days
Secondary outcomes (1)
Hearing improvement
Change from baseline to Day 30 of Pure Tone Audiometry(250 Hz、500 Hz、1000 Hz、2000 Hz、3000 Hz、4000 Hz、8000 Hz)
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start23 Jun 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- HY01 will be administrated on D1, D4 and D7, and no other drugs or treatments will be given during the trial period (D1-30).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heyu (Suzhou) Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Pin, Doctor, Study director, Shanghai Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961099
- Sponsor's protocol ID
- HY01-I-001
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Safety, Tolerance, Efficacy and Pharmacokinetics of Repeated Intratympanic HY01 in Patients With Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT04961099
- Acronym / sponsor ID
- HY01-I-001
- Conditions
- Sudden Sensorineural Hearing Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Heyu (Suzhou) Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 14 Jul 2021 (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.
Phase I clinical study on the safety, tolerance, efficacy and pharmacokinetics of repeated intratympanic HY01 in patients with sudden sensorineural hearing loss. In this study, low-dose group and high-dose group were designed, 6 cases in each group.
Detailed description
The incidence rate of sudden deafness is increasing year by year, which can cause severe hearing loss. Intratympanic HY01 can increase the local drug concentration in the ear, which is equal to or better than that in the treatment of sudden sensorineural hearing loss, and reduce the systemic drug concentration at the same time. It has obvious clinical value for the treatment of hormone forbidden population.
HY01 is one of glucocorticoid drugs. In this study, we designed low-dose group and high-dose group of HY01, and enrolled 6 patients with sudden sensorineural hearing loss for salvage therapy in each group. HY01 will be administrated on D1, D4 and D7 . The trial will be ended 30 days after the first administration.
After determining the safety of low-dose, the patients in the high-dose group will be enrolled. The safety observation indexes included systemic Routine Indexes and otology indexes, and the efficacy and pharmacokinetics were observed at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- HY01 will be administrated on D1, D4 and D7, and no other drugs or treatments will be given during the trial period (D1-30).
| Arm | Type | Receives |
|---|---|---|
| low-dose group | Experimental | Drug: HY01low-dose group: HY01 10mg（20mg/ml） |
| high-dose group | Experimental | Drug: HY01high-dose group: HY01 20mg（40mg/ml） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chinese subjects were 18-65 years old (including boundary value), male and female were not limited;
- Patients with unilateral sudden deafness;
- At least 7 days after the last medication (according to the guidelines for diagnosis and treatment of sudden deafness, the drugs allowed to be used include glucocorticoids, batroxobin, neurotrophic drugs (such as Mecobalamin, neurotrophic factors, etc.), antioxidants (such as lipoic acid, Ginkgo biloba extract, etc.) and lidocaine) ;
- The hearing recovery of patients with sudden deafness after initial treatment is less than 15dB or less than 50% of the hearing of the affected ear or the healthy ear before the onset of the disease ;
- 19≤BMI<26kg/m2；
Key exclusion criteria (27 listed)
- Ear diseases
- Patients with bilateral sudden deafness;
- The initial treatment was intratympanic glucocorticoid;
- The average hearing threshold of healthy ear was more than 25 dB;
- Patients with previous or current ear related diseases may affect the judgment of adverse events, including but not limited to chronic ear infection, cholesteatoma, Meniere's disease, otosclerosis, fluctuating hearing loss, acoustic trauma, autoimmune hearing loss, radiation-induced hearing loss, syphilitic deafness, endolymphatic hydrops, hearing loss caused by otological surgery Suspected retrocochlear lesions, suspected perilymph fistula or membrane rupture, perilymph fistula or barotrauma, acoustic neuroma, synchronous tinnitus (possibly caused by glomus jugulare tumor), skull, face or temporal bone abnormalities;
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 |
|---|---|---|
| HY01low-dose group: HY01 10mg（20mg/ml）, administrated on D1, D4 and D7 high-dose group: HY01 20mg（40mg/ml）, administrated on D1, D4 and D7 | Drug | high-dose group, low-dose group |
Primary outcome
Safety of HY01
Time frame: Throughout the study approximately 30 days
AEs and SAEs
1 secondary outcome
Hearing improvement
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- 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. This study is not recruiting at the moment.
Dong Pin, Doctor study director
Shanghai Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HY01 in people with Sudden Sensorineural Hearing Loss, run by Heyu (Suzhou) Pharmaceutical Technology Co., Ltd 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 7 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 14 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ding Xueying, Doctor (86 021-36123569, dingxueying@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of HY01 (time frame: Throughout the study approximately 30 days). 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 14 Jul 2021.