A Phase 1 Clinical study, Safety, Tolerability and PK of SP-8203
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0001742
- Lead Sponsor
- Shin Poong Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
1. Subject is male or female between the ages of 20 and 45 years, inclusive.
2. Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal. Non-pregnancy will be confirmed by serum pregnancy tests conducted at Screening, CRU admission, and at the Follow-Up Visit.
3. Males must be agree to practice a medically acceptable method of birth control and will not donate sperm during the study.
4. Subject’s body mass index (BMI) is = 18 kg/m2 and = 32 kg/m2, inclusive.
5. Subject does not smoke and has not smoked or used nicotine-containing products for at least 180 continuous days prior to the first dose.
6. Subject has adequate venous access for repeated venipuncture.
7. Subject has hemoglobin = 11.5 g/dL.
8. Subject agrees to abstain from taking any dietary supplements or non-prescription drugs (except for multi-vitamins, or as otherwise authorized by the Investigator and Medical Monitor) for 14 days prior to CRU admission through discharge.
9. Subject agrees to abstain from consuming alcohol-containing beverages for 3 days prior to CRU admission through discharge.
10. Subject agrees to abstain from consuming caffeine- or chocolate-containing products from CRU admission through discharge.
11. Subject is in general good health based on medical history and clinically acceptable results on the following assessments: physical examination, vital signs, 12 lead ECG, clinical chemistry, hematology/coagulation, and urinalysis.
12. Seated systolic blood pressure must be > 90 mmHg and = 140 mmHg and seated diastolic blood pressure must be >50 mmHg and = 90 mmHg at Screening and Baseline.
13. Subject voluntarily provides written informed consent to participate in the study in English, or a local language understood by both the investigator and subject. Subject is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
1. Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
2. Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important idiosyncratic reaction to any drug.
3. Subject has a predisposing condition that could interfere with the distribution, metabolism, or excretion of drugs or any condition that may confound the Pharmacokinetics(PK) analyses.
4. Subject tests positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus.
5. Subjects that have chronic QT prolongation syndrome (i.e. QTc > 450 ms for males and > 470 ms for females) in repeated Electrocardiography(EKG) measurements.
6. Subject used any drugs or substances known to inhibit or induce cytochrome P450 2D6 (CYP) enzymes within 28 days prior to the first dose and throughout the study.
7. Subject has a recent (2-year) history of alcoholism or drug abuse.
8. Subject tests positive for alcohol or drugs of abuse at the Screening Visit or upon admission to the CRU.
9. Subject has been on a special diet during the 28 days prior to the first dose (eg, Atkins, South Beach, or any other high protein / high fat diets).
10. Subject reports difficulty fasting or consuming standardized meals.
11. Subject has donated of plasma (apheresis) within 30 days and whole blood within 60 days prior to the first dose of study medication.
12. Subject who participated in another clinical trial within 90 days prior to dosing.
13. Subject has a history of malignancy within the past 5 years, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
14. For any other reason that investigator believes the subject is not suitable to participate.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety of SP-8203 will be evaluated by monitoring treatment-emergent AE, changes in 12-lead ECG, clinical laboratory tests, vital signs, and physical examinations.
- Secondary Outcome Measures
Name Time Method Plasma concentration of SP-8203 and PK will be determined. Urine will be collected for the determination of renal clearnace. ;The efficacy of SP-8203 is not being evaluated in this study. The biomarkers Mn-SOD, FRAP and MMP-9 will be assayed for signals of potential efficacy.