Phase I Clinical Study of HY01 in Patients

NCT04961099 | Unknown Phase 1

• 1 other identifier: HY01-I-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Safety of HY01

  AEs and SAEs

  Throughout the study approximately 30 days

Secondary Outcomes (1)

• Hearing improvement

  Day 30

Study Arms (2)

low-dose group

EXPERIMENTAL

low-dose group: HY01 10mg（20mg/ml）

Drug: HY01

high-dose group

EXPERIMENTAL

high-dose group: HY01 20mg（40mg/ml）

Drug: HY01

Interventions

HY01 DRUG

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

high-dose group; low-dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• ≤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.

You may not qualify if:

• \- 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;
• 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;

Sponsors & Collaborators

• Heyu (Suzhou) Pharmaceutical Technology Co., Ltd: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200940, China

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sudden

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong Pin, Doctor

  Shanghai Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Ding Xueying, Doctor

CONTACT

86 021-36123569; dingxueying@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HY01 will be administrated on D1, D4 and D7, and no other drugs or treatments will be given during the trial period (D1-30).

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: July 14, 2021
• Study Start: June 23, 2021
• Primary Completion: October 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)