A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0009422
- Lead Sponsor
- euracle Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 118
[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
[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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1b part: Change from Baseline in Safety Profiles (Adverse Event, Serious Adverse Event, ratio of Treatment related Serisous Adverse Event with causality & severity will be descriptively measured and collected in the following time frames);Phase 2a part: Changes from Baseline in Safety Profiles (Adverse Event, Serious Adverse Event, ratio of Treatment related Serisous Adverse Event with causality & severity will be descriptively measured and collected in the following time frames)
- Secondary Outcome Measures
Name Time Method Phase 1b part: Change from Baseline in PK/PD profiles & Immunological Assay (Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve);Phase 2b part : Change from Baseline in PK/PD profiles & immunological Assay (Concentrations, Areas Under the Curve versus time curve, Times and Volumes of Distribution of various status verus time curve)