Phase I Clinical Study of HY01 in Patients

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Brief Title

Phase I Clinical Study of HY01 in Patients

Official Title

Phase I Clinical Study on the Safety, Tolerance, Efficacy and Pharmacokinetics of Repeated Intratympanic HY01 in Patients With Sudden Sensorineural Hearing Loss

Brief 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.
    

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety of HY01

Secondary Outcome

 Hearing improvement

Condition

Sudden Sensorineural Hearing Loss

Intervention

HY01

Study Arms / Comparison Groups

 low-dose group
Description:  low-dose group: HY01 10mg(20mg/ml)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

June 23, 2021

Completion Date

June 30, 2022

Primary Completion Date

October 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Chinese subjects were 18-65 years old (including boundary value), male and female were
             not limited;

          2. Patients with unilateral sudden deafness;

          3. 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) ;

          4. 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 ;

          5. 19≤BMI<26kg/m2;

          6. 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) ;

          7. The informed consent was signed before the trial, and the trial content, process and
             possible adverse reactions were fully understood.

        Exclusion Criteria:

        - Ear diseases

          1. Patients with bilateral sudden deafness;

          2. The initial treatment was intratympanic glucocorticoid;

          3. The average hearing threshold of healthy ear was more than 25 dB;

          4. 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;

          5. Subjects with congenital deafness and hereditary deafness;

          6. Treatment history of ototoxicity drugs within 6 months, such as chemotherapy, loop
             diuretics, aminoglycosides, quinine, high-dose aspirin, etc;

          7. Subjects considered unsuitable for this clinical study.

             Systemic diseases

          8. Previous or current contraindications to glucocorticoids include hypertension,
             thrombosis, myocardial infarction, gastric and duodenal ulcer, visceral surgery,
             psychosis, electrolyte metabolism abnormality, glaucoma;

          9. 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;

         10. Corticosteroid related psychiatric reactions;

         11. 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;

         12. Subjects with positive TB history or tuberculin test (PPD);

         13. Type 1 and type 2 diabetes;

         14. pancreatitis;

         15. Suffering from rheumatic diseases, such as rheumatoid arthritis, scleroderma, lupus,
             etc;

         16. Previous or current use of chemotherapy or immunosuppressive drugs;

         17. Active herpes zoster;

         18. Those who had taken any medicine other than sudden deafness within 14 days before the
             first administration;

         19. There was a history of alcohol abuse and drug abuse in one year before screening;

         20. Those who had participated in any clinical trial within 3 months before the first
             administration of the trial;

         21. Blood donation or blood loss ≥ 200ml within 3 months before the first administration;

         22. 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;

         23. 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;

         24. Serological tests or other tests showed that subjects with positive hepatitis B, HCV,
             syphilis and AIDS were positive.

         25. Subjects considered unsuitable for this clinical study.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Dong Pin, Doctor, 86 021-36123569, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04961099

Organization ID

HY01-I-001


Responsible Party

Sponsor

Study Sponsor

Heyu (Suzhou) Pharmaceutical Technology Co., Ltd


Study Sponsor

Dong Pin, Doctor, Study Director, Shanghai Central Hospital


Verification Date

June 2021