KCT0005706已完成未知
A Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Pharmacodynamic biomarker of JAK inhibitor in Healthy Male Subjects
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1) Healthy male subjects aged 19-55 years
- •2) Subjects with weight between 50.0 kg and 90.0 kg and BMI between 18.0 kg/m2 and 30.0 kg/m2
- •3) Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures
- •4) Subject who judged eligible for the study from vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests and medical interviews
排除标准
- •1) Subject with a history or presence of clinically significant active disease of the hepatic, renal, neurological, pulmonary, endocrine, hematological, oncological, genitourinary or psychiatric system. Especially subject with clinically significant infections(e.g. sepsis), active tuberculosis or untreated latent tuberculosis
- •2) Subject with history or presence of diseases or any major surgery that can affect pharmacokinetic or pharmacodynamics evaluation (except for appendectomy or repair of hernia)
- •3) Subject with or with history of rheumatoid arthritis
- •4) Subject with or with history of symptomatic herpes simplex or varicella-zoster within three months before first expected administration
- •5) Subject with or expected to have inoculation for live vaccine within three months before first expected administration
- •6) Subject with hypersensitivity to JAK inhibitor or other medication or clinically significant history of hypersensitivity
- •7) Subject positive for serology tests (HBV, HCV, HIV) at screening
- •8) Subject positive for IGRA at screening
- •6) Subject with any of following results:
- •- AST or ALT exceeding 1.5 x ULN
- •- Creatinine exceeding ULN
- •- ANC less than 2000/uL
- •- ALC less than 500/uL
- •- Hb less than 12.5 g/dL
- •- Platelet less than 150000/uL
- •- QTc interval > 450 msec at 12-lead ECG
- •10) Subject with systolic blood pressure > 140 mmHg or < 90 mg; diastolic blood pressure > 95 mmHg or < 50 mmHg
- •11) Subject with history of drug abuse or positive result in urine drug screening
- •12) Within 14 days prior to study medication, use of prescription drug or herbal medication or within 7 days use of any over-the-counter medications (if washout periods are more than 5 half-lives of the drug, can be eligible considering absorption, distribution, metabolism and excretion by the investigator’s judgment)
- •13) Subject who was administerd of another investigational drug (including investigational drug of bioequivalence trial) within 6 months prior to planned administration of the study medication
- •14) Subject who donated whole blood within 2 months prior to the first administration or blood component donation within 1 month prior to the first administration
- •15) Subject who smoke excessively (cigarettes > 10 per day) or who cannot quit smoking from 24 hour prior to admission to discharge
- •16) Subject who cannot quit drinking caffeine containing beverages (coffee, black tea, green tea, cokes, coffee milk or energy drink) during the hospitalization
- •17) Subject who consumed grapefruit containing food from 24 hour prior to admission to discharge or who cannot quit consuming during the period
- •18) Subject who do not use medically acceptable contraceptive method during whole study period
- •? Medically acceptable contraceptive method
- •- intrauterine contraception/device
- •- barrier methods (female condom, diaphragm, sponge, cervical cap) together with spermicidal foam/gel/film/cream/suppository
- •- surgical sterilization (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
- •19) Subject who investigator judged ineligible for other reasons
研究者
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