KCT0009422招募中Unknown
A Phase 1b/2a, Double-blinded, Placebo-controlled, Multiple Doses, 2 Step-up Study Evaluating the Safety, Tolerability, PK/PD and Efficacy of Systemic NS101 in Healthy Volunteers and SSNHL Patients
euracle Science0 个研究点目标入组 118 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 118
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
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •[Part A inclusion criteria]
- •1. Adults aged 19 to 65 years old at the time of signing the consent form
- •2. Those who weigh more than 50.0 kg and have BMI over 18.5 kg/m2 under 30.0 kg/m2
- •3. Those who agree to use an appropriate medically recognized double contraception method and not to donate sperm for up to 3 months after administration of the investigational drug
- •4. Those who understand the purpose of this clinical study, voluntarily decide to participate in the clinical study, and give written consent to comply with the restrictions
- •[Part B inclusion criteria]
- •1.Adults aged 19 to 65 years old at the time of signing the consent form
- •2.Those who are willing and able to comply with requirements for the entire study period
- •3.Those who weigh more than 50.0 kg and have BMI over 18.5 kg/m2 under 30.0 kg/m2
- •4.Unilateral idiopathic SSNHL greater than 55 dB at the average of 4 frequencies at 0.5, 1, 2 and 4 kHz in PTA (contralateral hearing 30 dB under)
- •5.Those who started standard treatment (refer to inclusion criteria 6) within 5 days after symptom onset (i.g. including cases where standard treatment was administered within 5 days of symptom onset at an institution or local clinic); and
- •6.Those who were treated with oral steroids (Prednisolone 1mg/kg/day, maximum daily dose 60mg, 7-day full dose, 7-day tapering to physiologic dose of prednisolone 10mg) for 14 days, but incomplete recovery was confirmed as type III/IV according to Siegel's criteria (see Appendix A) at the end of the 14-day treatment
- •7.Female subjects of childbearing age: Those who agree to use a medically effective dual contraceptive method for at least 1 month before the screening visit and to use the method during study participation and for 3 months thereafter. The definitions of non-fertile women are as follows.
- •Postmenopausal women (no menstruation for more than 12 months without any other medical reason)
- •Those who had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/obstruction at least 6 weeks prior to the screening visit; or
- •Those with a congenital or acquired condition that prevents pregnancy
- •8.Male subjects who have not undergone sterilization and have female partners of childbearing potential: Those who agree to double contraception using condoms or other methods to ensure effective contraception with their partner during the study participation period and for the following 3 months
排除标准
- •[Part A exclusion criteria]
- •1.Those with or have a history of clinically significant cardiovascular, respiratory, liver, kidney, hematological, gastrointestinal, endocrine, immune, skin, nervous, or mental disorders
- •2.Those who have symptoms of an acute illness within 28 days prior to administration of investigational drug or who have undergone surgery within a month
- •3.Those with a medical history that may affect drug absorption, distribution, metabolism, and excretion
- •4.Those with clinically significant active chronic disease
- •5.Those who are positive for hepatitis B or C or HIV or VDRL infection
- •6.Those who are positive for urine drug test (TBPE test) or breath alcohol test (BrAC) at the time of screening
- •7.Those with clinically significant allergic diseases (However, mild allergic rhinitis and allergic dermatitis that do not require medication may be included) or those with a history of anaphylactic reaction or hypersensitivity to the investigational drug or its components
- •8.Those who have a history of alcohol abuse within 1 year prior to the screening visit or who have consumed more than 14 units of alcohol per week or 3-4 units per day within 6 months (e.g. 1 unit: 150 mL of wine, 360 mL of beer, 45 mL of 40% alcohol)
- •9.Those with a history of drug abuse or drug use (marijuana, cocaine, phencyclidine, crack, opioid derivatives including heroin, amphetamine derivative, etc.) prior to the screening visit
- •10.Those who have continuously consumed excessive caffeine (e.g. more than 3 cups of coffee per day) or excessive smokers (e.g. over 10 cigarettes per day) within 1 month prior to the screening visit
- •11.Pregnant or lactating women
- •12.Those who have been vaccinated, including COVID-19 vaccine, within 1 month before the first dose of investigational drug
- •13.Those who participated in another clinical study and received investigational drugs or biological agents or immunosuppressants within 6 months before the first administration of investigational drugs
- •14.Those who have taken over-the-counter medicines (e.g. except when using acetaminophen (up to 2 g per day)), health functional foods, or vitamin preparations (including food supplements and sports supplements such as herbal medicine, probiotics, vitamins, minerals, amino acids, essential fatty acids, proteins, etc.) within 7 days before the first administration of the investigational drug
- •15.Those who received a depot injection or transplant within 3 months before the first administration of the investigational drug
- •16.Those who receive treatment that may cause rapid weight gain or loss or participate in a structured weight loss program within 1 month prior to the first administration of the investigational drug
- •17.Those who donated whole blood within 2 months or apheresis blood within 1 month before the first administration of the investigational drug, or received immunoglobulin or blood transfusion within 1 month
- •18.Those with a history of blood diseases such as thrombocytopenia, thrombocytosis, camellia/venous thromboembolism, etc.
- •19.Those with a history of lymphatic disorder
- •20.Those with a history of malignant tumor or who have received an organ transplant or bone marrow transplant
- •21.Those with a significant neuropsychiatric history such as seizures, traumatic brain injury, schizophrenia, or bipolar disorder
- •22.Those who are judged by the investigator to be unsuitable for participation in this study due to abnormal screening resul
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