KCT0004830
Completed
未知
A First-in-Human, Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of WK0202 Capsule in Single and Multiple Ascending Dose in Healthy Adult Male and Female Subjects
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Seoul National University Hospital
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy adult aged 19 \~ 45 on the day of screening
- •2\) Weight \= 50\.0kg, 18\.0 \= BMI \= 27\.0
- •? Body Mass Index (BMI, kg/m2\) \= Weight (kg)/\[height(m)2]
- •3\) During the study period, female subjects must agree to use following contraception or female partners of male subjects must be as follows,
- •? Female subjects or female partners of male subjects is in menopause (more than 12 months of non\-therapy induced amenorrhoea)
- •? Female subjects or female partners of male subjects is surgically infertile (Ovary and/or uterus removed)
- •? Subject who agreed to absolute abstinence during the study period \[for female subjects, intermittent abstinence (e.g., ovulation period, symptothermal method, ovulation secretory phase) or external ejaculation does not meet absolute abstinence]
- •? If female subjects or female partners of male subjects are women of childbearing potential(WOCBP) that did not receive sterilization operation, they must agree to the following method of contraception
- •a. Both female subjects and female partners of male subjects apply: intrauterine contraception / ovarian conjunctomy and sterilization operation / combination use of condoms or diaphragm and spermicide
- •b. Male subjects (does not apply for male partners of female subjects): Combination use of condom and spermicide
Exclusion Criteria
- •1\) Subject with a history or evidence of clinically significant hepatic (severe liver dysfunction, etc.), renal (severe kidney dysfunction, etc.), neuronal, immunologic, respiratory, endocrinal, hematologic (except in cases where no such disease has occurred for more than 10 years or where malignant tumors are only basal or squamous cell carcinoma of the skin), cardiovascular (cardiac failure, Torsades de pointes, etc.), psychiatric disease or disorder
- •2\) Subject with a history of gastrointestinal disease (Crohn's disease, ulcer, etc.) or surgery (exception: simple appendectomy and hernia surgery) which could affect the safety, pharmacokinetic/pharmacodynamic evaluation of the test drug
- •3\) Subject with a history of clinically significant hypersensitive reactions to WK0202, drugs that consists of/related to WK0202, or other drugs(aspirin, antibiotics, etc.)
- •4\) Subject who was deemed unfit for the study in a screen test conducted within 28 days prior to the administration
- •(1\) If the blood AST, ALT level is above the upper limit of the normal range by \> 1\.5 times
- •(2\) If the total bilirubin level is above the upper limit of the normal range by \> 1\.5 times
- •(3\) If the blood CPK level is above the upper limit of the normal range by \> 1\.5 times
- •(4\) If the estimated glomerular filtration rate (eGFR) determined by modification of diet in renal disease (MDRD) is \< 90 mL/min/1\.73m2
- •(5\) If the subject tested positive in a serum test (type B hepatitis, type C hepatitis, human immunodeficiency virus (HIV) test)
- •(6\) If the subject has vital signs of systolic blood pressure of \> 150 mmHg or \< 90 mmHg, or diastolic blood pressure of \> 100 mmHg or \< 50 mmHg
Outcomes
Primary Outcomes
Not specified
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