A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Tmax,ss of multiple doses of CJ-15314
研究概览
简要总结
This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.
详细描述
- To evaluate the safety, tolerability and pharmacokinetics of single or multiple dose of CJ-15314 phosphate in healthy male subjects
- To explore the pharmacodynamics of single or multiple dose of CJ-15314 phosphate in healthy male subjects
- To explore the pharmacokinetics of CJ-15314 Phosphate active metabolites of single or multiple dose of CJ-15314 phosphate in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
- •Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m^2 with a body weight ≥ 50.0 kg and ≤ 90.0 kg at screening.
- •☞ BMI (kg/m^2) = weight (kg) / {height (m)}^2
- •Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure.
- •Determined eligible for this study in the opinion of the investigator based on the results of vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests, and medical interview drug screening test.
排除标准
- •Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- •Has a history or current evidence of gastrointestinal disease that may affect the safety and PD assessment of IP or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- •Has rheumatoid arthritis or has a history.
- •Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
- •Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
- •Has a history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of Janus kinase inhibitor and other drugs.
- •Has a positive result on serology tests (for hepatitis B, hepatitis C and human immunodeficiency virus [HIV]) during screening test.
- •Has abnormalities one or more of the following during screening test: AST [GOT] or ALT [GPT] > 1.5 X upper limit of normal (ULN), Creatinine > upper limit of normal (ULN), ANC < 2,000/uL, Hb <12.5 g/dL, Platelet < 150,000/uL, QTc interval at 12-lead electrocardiogram > 450 msec
- •Systolic blood pressure (SBP) < 90 mmHg or > 140 mmHg, diastolic blood pressure (DBP) < 50 mmHg or > 95 mm Hg, or pulse rate (PR) < 45 beats/min or > 100 beats/min on vital signs measured in sitting position after taking a rest for at least 5 minutes during screening test.
- •Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
- •Has taken any prescription drugs or herbal medicine within 2 weeks prior to the expected date of first dose, or has taken or is expected to take any over-the-counter (OTC) drug, health functional food or vitamin preparation within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise eligible in the judgment of the investigator).
- •Has participated in any other clinical study or bioequivalence study and received IPs within 6 months prior to the scheduled first dose.
- •Has donated whole blood within 2 months prior to the scheduled first dose, or has donated blood components or received transfusion within a month prior to the scheduled first dose.
- •Has a history of excessive smoking (> 10 cigarettes/day) within 3 months prior to the scheduled first dose or confirmed as positive for cotinine on urine drug screening test.
- •Excessive caffeine intake (> 5 units/day), continued use of alcohol (> 21 units/week, 1 unit = 10 g of pure alcohol), or unable to stop drinking during hospitalization period.
- •Unable to avoid caffeine-containing foods (e.g., coffee, tea [black tea, green tea, etc.], soda, coffee-flavored milk, and nutritive tonic drink) during the period from 24 hrs before hospitalization to discharge.
- •Unable to use a medically acceptable contraceptive method throughout the study.
- •► Medically acceptable contraceptive methods include:
- •Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)
- •Simultaneous use of (male or female) barrier method and spermicide
- •Surgical sterilization of the subject or his partner (e.g., vasectomy, salpingectomy, tubal ligation, or hysterectomy)
- •Determined ineligible for study participation by the investigator for other reasons such as clinical laboratory abnormalities.
研究组 & 干预措施
A dose as CJ-15314 or placebo
Oral administration of A as CJ-15314 or placebo once a day
干预措施: A dose as CJ-15314 (Drug)
A dose as CJ-15314 or placebo
Oral administration of A as CJ-15314 or placebo once a day
干预措施: Placebo (Drug)
B dose as CJ-15314 or placebo
Oral administration of B as CJ-15314 or placebo once a day
干预措施: B dose as CJ-15314 (Drug)
B dose as CJ-15314 or placebo
Oral administration of B as CJ-15314 or placebo once a day
干预措施: Placebo (Drug)
C dose as CJ-15314 or placebo
Oral administration of C as CJ-15314 or placebo once a day and once daily for 7 days
干预措施: C dose as CJ-15314 (Drug)
C dose as CJ-15314 or placebo
Oral administration of C as CJ-15314 or placebo once a day and once daily for 7 days
干预措施: Placebo (Drug)
D dose as CJ-15314 or placebo
Oral administration of D as CJ-15314 or placebo once a day and once daily for 7 days
干预措施: D dose as CJ-15314 (Drug)
D dose as CJ-15314 or placebo
Oral administration of D as CJ-15314 or placebo once a day and once daily for 7 days
干预措施: Placebo (Drug)
E dose as CJ-15314 or placebo
Oral administration of E as CJ-15314 or placebo once a day and once daily for 7 days
干预措施: E dose as CJ-15314 (Drug)
E dose as CJ-15314 or placebo
Oral administration of E as CJ-15314 or placebo once a day and once daily for 7 days
干预措施: Placebo (Drug)
F dose as CJ-15314 or placebo
Oral administration of F as CJ-15314 or placebo once a day and once daily for 7 days
干预措施: F dose as CJ-15314 (Drug)
F dose as CJ-15314 or placebo
Oral administration of F as CJ-15314 or placebo once a day and once daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Tmax,ss of multiple doses of CJ-15314
时间窗: Up to 72 hours
AUCtau,ss of multiple doses of CJ-15314
时间窗: Up to 72 hours
t1/2 of multiple doses of CJ-15314
时间窗: Up to 72 hours
PTF of multiple doses of CJ-15314
时间窗: Up to 72 hours
λz of single dose of CJ-15314
时间窗: Up to 72 hours
Cmax of single dose of CJ-15314
时间窗: Up to 72 hours
Tmax of single dose of CJ-15314
时间窗: Up to 72 hours
AUClast of single dose of CJ-15314
时间窗: Up to 72 hours
AUCinf of single dose of CJ-15314
时间窗: Up to 72 hours
t1/2 of single dose of CJ-15314
时间窗: Up to 72 hours
CL/F of single dose of CJ-15314
时间窗: Up to 72 hours
Cav,ss of multiple doses of CJ-15314
时间窗: Up to 72 hours
Cmax,ss of multiple doses of CJ-15314
时间窗: Up to 72 hours
Cmin,ss of multiple doses of CJ-15314
时间窗: Up to 72 hours
Vd/F of single dose of CJ-15314
时间窗: Up to 72 hours
Ae of single dose of CJ-15314
时间窗: Up to 72 hours
fe of single dose of CJ-15314
时间窗: Up to 72 hours
CLR of single dose of CJ-15314
时间窗: Up to 72 hours
Ra of multiple doses of CJ-15314
时间窗: Up to 72 hours
Ae of multiple doses of CJ-15314
时间窗: Up to 72 hours
fe of multiple doses of CJ-15314
时间窗: Up to 72 hours
CLR of multiple doses of CJ-15314
时间窗: Up to 72 hours
次要结局
- fe of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- Cmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- Tmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- AUClast of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- AUCinf of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- t1/2 of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- λz of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- Ae of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314(Up to 72 hours)
- Cmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- Cmin,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- Cav,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- Tmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- AUCtau,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- t1/2 of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- PTF of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- Ra of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- Ae of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)
- Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314(Up to 72 hours)