NCT04779892已完成1 期
The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours After the Single Infusion of CMAB008/Remicade
研究概览
简要总结
A phase 1, Randomized, Double-blind, Parallel group, Sing-dose study to compare the Pharmacokinetics and Safety of CMAB008 and Remicade in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subject (male) between the ages of 18 and 45 years.
- •Subject with a body weight of ≥50 kg and ≤ 80 kg and a BMI between 19.0~26.0 kg/m2 (both inclusive);
- •Healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram;
排除标准
- •Those who have surgered 4 weeks before signing the informed consent;
- •Those with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor, blood, endocrine, nervous and other system diseases, or those with any previous immune diseases;
- •Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, vitamins, dietary supplements, etc.) and health care products within 4 weeks before signing the informed consent;
- •Those who accepted biological drugs within 6 months before signing the informed consent, or accepted the TNF monoconal antibody drugs;
- •Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponema pallidum antibody is positive;
- •Either T cell immunospot test (T-SPOT) or antinuclear antibody is positive;
- •Those who have infected within 30 days before administration, or serious infection associated with hospitalisation and/or which required inrravenous antibiotics within 3 months before administration.
- •Vaccinated within 30 months before signing the informed conset, or plan to vaccinate during the trail;
- •Those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior to the trail; those who have positive drug abuse test results;
- •Those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 250ml per cup) every day;
- •Those who have a blood donation history of 400 ml within 3 months, or 200 ml within 1 month;
- •Those who have a history of drug or food allergy, or are known to be allergic to any component of the test drug or latex, etc.
- •Those who are addicted to smoking or smoke more than 10 cigarettes per day on average within 6 months before signing the informed consent;
- •Alcoholics or regular drinkers within 3 months before the trail, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive;
- •Those who plan to donate sperm within 6 months after the adminstration of the test drug;
研究组 & 干预措施
CMAB008
Experimental
干预措施: Infliximab (Drug)
Remicade
Active Comparator
干预措施: Infliximab (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours After the Single Infusion of CMAB008/Remicade
时间窗: up to 1680 hours
次要结局
- Total Frequency of AE/SAE Within the Whole Time of the Study(up to 1680 hours)
- Time of Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade(up to 1680 hours)
- Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single Infusion of CMAB008/Remicade(up to 1680 hours)
- Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade(up to 1680 hours)
- Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected(up to 1680 hours)
研究者
研究点 (1)
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