NL-OMON55334已完成不适用
First-in-human, placebo-controlled, ascending dose study to assess the safety, tolerability and pharmacokinetics of a single intratympanic injection of AC102 in healthy volunteers - Niet van toepassing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
- •approved informed consent form (ICF)
- •2. Willing and able to attend the trial visits
- •3. Able to read and understand trial documents and follow Investigator and
- •trial personnel instructions during visits, including audiology measurements
- •4. Female or male
- •5. Age * 18 years and * 40 years at the day of Screening
- •6. Body mass index (BMI) 18.0 - 30.0 kg/m2, inclusive, where BMI (kg/m2) <= body
- •weight (kg) / height2*(m2) at Screening Visit
- •7. Healthy as judged by a responsible physician with no clinically significant
- •abnormality identified on the medical or laboratory evaluation, including
- •12-lead ECG, vital sign assessment or physical examination
- •8. Normal age-related hearing in both ears according to DIN EN ISO 8253-1 and
- •DIN 7029:2017
- •9. Willing and able to use adequate hearing protection and to refrain from
- •engaging in activities or work involving loud noise exposure where sufficient
- •hearing protection is not possible or ensured for the duration of their
- •participation in this study
- •10. Willing and able to protect the ear canal and middle ear from water
- •exposure for as long as the tympanic membrane is not fully closed
- •11. A female volunteer must meet one of the following criteria:
- •* If of childbearing potential * agrees to use one of the accepted
- •contraceptive regimens from at least 28 days prior to until at least 30 days
- •after study medication administration. An acceptable method of contraception
- •includes at least one of the following:
- •a. Abstinence from heterosexual intercourse
- •b. Combined (contains estrogen and progestogen) hormonal contraception (oral,
- •vaginal, transdermal)
- •c. Progestogen only contraception (oral, injectable, implantable)
- •d. Intrauterine device
- •e. Intrauterine hormone-releasing system
- •f. Bilateral tubal ligation
- •g. Vasectomized partner
- •* If of non-childbearing potential * should be surgically sterile (i.e. has
- •undergone complete hysterectomy, bilateral oophorectomy, or bilateral tubal
- •ligation) or in a postmenopausal state (at least one year without menses at
- •12. A male volunteer with sexual partners who are pregnant, possibly pregnant,
- •or who could become pregnant must meet the following criteria:
- •* Subject is unable to procreate, defined as surgically sterile (i.e. has
- •undergone a vasectomy at last 6 months before Screening)
- •* Subject agrees to use one of the accepted contraceptive regimens until 90
- •days after study medication administration. An acceptable method of
- •contraception includes one of the following:
- •a. Abstinence from heterosexual intercourse
- •b. Condom with spermicide.
排除标准
- •1. History of acute hearing loss from noise trauma, barotrauma or head trauma
- •in either ear at any time
- •2. History of idiopathic sudden sensorineural hearing loss in the past 2 years
- •3. Congenital hearing loss
- •4. History of chronic (> 6 months) noise exposure (for leisure or profession)
- •5. Chronic or acute tinnitus in either ear
- •6. Current vertigo/previous balance or vestibular disorders
- •7. Any clinically significant external or middle-ear pathology observed by
- •otoscopic examination or tympanometry (i.e. reduced mobility of the tympanic
- •8. Any clinically significant abnormality of the tympanic membrane or the outer
- •ear canal in the selected ear that would preclude intratympanic administration
- •9. Absence of detectable OAEs in the frequency band with a concomitant
- •clinically significant increase in hearing thresholds in accordance with DIN EN
- •ISO 8253-1 and DIN 7029:2017
- •10. Known family history of hearing impairment, other than age related
- •11. History of autoimmune hearing loss, radiation-induced hearing loss,
- •fluctuating hearing, endolymphatic hydrops or Menière*s disease in either ear
- •12. History of chronic inflammatory or suppurative ear disease or cholesteatoma
- •13. Current evidence or history of acoustic neuroma or other retrocochlear
- •14. History of otosclerosis
- •15. Suspected perilymph fistula or membrane rupture in either ear
- •16. Otitis media or otitis externa that is ongoing or ended within 30 days
- •prior to study treatment or is occurring several times per year
- •17. Radiation therapy in the head and neck area
- •18. Any therapy known as ototoxic (e.g. aminoglycosides [systemic or
- •ototopical], cisplatin, loop diuretics, quinine etc.)
- •19. Taking any anti-coagulant medication (direct oral anticoagulant [DOAC],
- •e.g. Apixaban®), vitamin K antagonists (e.g. Marcumar®), thrombocyte
- •aggregation blockers (e.g. Aspirin®) chronically or Aspirin® as a pain killer
- •acutely within one week before treatment
- •20. History or presence of drug abuse or alcoholism within the past 2 years
- •21. Positive urine screen of drugs of abuse (if not due to concomitant
- •medication, e.g. benzodiazepines as hypnotics) or alcohol breath test at
- •Screening or Day -1
- •22. Ingestion of alcohol within 48 hours prior to study medication
- •administration and during the in-house period.
- •23. Current smokers
- •24. Excess in xanthine consumption (more than 5 cups of coffee/day or
- •equivalent)
- •25. Subjects with diagnosed anxiety disorders, psychosis, depression,
- •schizophrenia, attempted suicide or other significant psychiatric conditions
- •that can impact their ability to cooperate and comply with the study protocol
- •26. Any clinically relevant autoimmune, respiratory, cardiovascular, hepatic,
- •gastrointestinal, renal, dermatological, neurological or other abnormality that
- •in the opinion of the Investigator may pose a safety risk to a subject in this
- •study, which may confound safety assessment, or may interfere with study
- •participation or the evaluation of study treatment
- •27. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- •28. Having an active infection with SARS-CoV-2
- •29. Abnormal and clinically relevant laboratory results
- 另有 3 项未显示
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