Clinical trial to evaluate safety, tolerability and pharmacokinetic characteristics of MIT-001 after subcutaneous and intravenous administration in healthy subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0007427
- Lead Sponsor
- MitoImmune Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. A healthy adult between 19 and 45 at the time of screening
2. A person who weigh 55 kg or more and 90 kg or less at the time of screening and have a body mass index (BMI) of 18.0 or more and 27.0 or less ? BMI (kg/m2) = Weight (kg) / {Height (m)}2
3. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and consents in writing before the screening procedure
4. A person suitable as a test subject for this study when judged by the investigator through physical examination, clinical laboratory examination, questionnaire, etc.
1. Clinically significant liver, kidney, nervous, immune, respiratory, endocrine system disease, blood/tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or a history of above diseases
2. A person with a history of hypersensitivity or clinically significant hypersensitivity to investigational drugs, drugs containing the same class of ingredients, and other drugs (aspirin, antibiotics, etc.)
3. At screening, QTc > 450 ms on ECG or other clinically significant findings
4. A person with AST and ALT exceeding 1.5 times the upper limit of the normal range during screening
5. A person with eGFR of less than 60 mL/min/1.73m2 measured using the CKD EPI formula in clinical laboratory tests at screening
6. At screening, systolic blood pressure > 160 mmHg or < 90 mmHg, or diastolic blood pressure > 100 mmHg or < 50 mmHg
7. A person with a history of drug abuse or who have tested positive for drugs of abuse in urine drug screening tests
8. A person who has taken any prescription drugs or herbal medicines within 2 weeks before the first scheduled administration date, or have taken any over-the-counter (OTC), health functional food, or vitamin preparations within 1 week In cases where it is reasonable, they can participate in the clinical trial) or those who are expected to take it
9. A person who has taken drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first scheduled administration date
10. A person who has participated in other clinical trials or bioequivalence studies within 6 months prior to the scheduled first administration date and received the investigational drug or bioequivalence study drug
11. A person who has donated whole blood within 2 months before the first scheduled dose or donated component blood within 1 month, or received blood transfusion within 1 month before the first scheduled dose
12. A person who continuously drinks alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol (? 1 glass of soju or 250 mL of beer)) or cannot abstain from alcohol during the clinical trial period
13. Smokers (However, if you quit smoking 3 months before the first scheduled dose, you can be selected as a test subject)
14. A person who has consumed caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated drinks, coffee milk, nourishing drinks, etc.) within 24 hours of hospitalization for clinical trials and those who cannot refrain from consuming them during hospitalization
15, A person agreed to contraception during the clinical trial period and up to 1 month
16. Pregnant or lactating women
17. A person who judged the investigator to be inappropriate to participate in the clinical trial due to other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerance.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics variables ( Cmax, Cmin, Cavg, AUCtau, Tmax, t1/2, Vd/F, CL/F, Cmax,ss, Cmin,ss, Cavg,ss, AUCtau,ss, Tmax,ss, t1/2,ss, Vdss/F, CLss/F,PTF, Rac)