NCT04778137已完成1 期
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD 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
- 114
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Outcome Measures [AUC0-inf]
研究概览
简要总结
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and Xolair) 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 between the ages of 18 and 45 years.
- •Subject with a body weight of ≥50 kg and ≤ 75kg and a BMI between 19.0~26.0 kg/m2 (both inclusive).
排除标准
- •subject has a medical history and/or current presence of disease
- •subject has undergone surgery within three months before signing the informed consent;
- •Alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 unites 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 have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior the trial; those who have positive drug abuse test results;
- •Those who smoke more than 10 cigarettes per day on average in the 6 months before signing the informed consent; or those who have positive nocotine results;
- •Those who have a history of drug or food allergy, or who have special allergy history (asthma, urticaria, etc.); those who have allergic rhinitis, or are known to be allergic to any component of the test drug or latex (contained in the syringe needle cover);
- •Those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) every day;
- •Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, etc.) and health care products within 4 weeks befor signing the informed consent;
- •Those who have a blood donation over 400 ml within 3 months, or 200 ml within 1 month before signing the informed consent, or plan to donate blood during the trail;
- •Those who accept any biological drugs within 3 months, or anti-IgE biological drugs within 12 months before signing the informed consent;
- •Those who plan to donate sperm within 6 months after the administration of the test drug;
- •Participants in other clinical trails within 3 months before signing the informed consent;
- •Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponerma pallidum antibody is positive;
- •The results of medical examination (ECG, X-ray, B-ultrasonic, physical and laboratory examination) are clinical significant abnormalities according to the judgment of the researcher;
- •Anti-nuclear antibody or fecal parasite test is positive;
- •Those who have undergone surgery within 1 months before signing the informed consent, or plan to undergo surgery during the trail period;
研究组 & 干预措施
CMAB007
Experimental
75mg×2
干预措施: Omalizumab (Drug)
Xolair
Active Comparator
150mg
干预措施: Omalizumab (Drug)
结局指标
主要结局
Pharmacokinetic Outcome Measures [AUC0-inf]
时间窗: up to day 106
Area Under the Concentration-time Curve from Time zero to infinity (AUC0-inf) of CMAB007 and Xolair in healthy subjects.
Pharmacokinetic Outcome Measures [Cmax]
时间窗: up to day 106
Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects.
次要结局
- Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)](up to day 106)
- Pharmacokinetic Outcome Measures [Tmax](up to day 106)
- Pharmacokinetic Outcome Measures [λz](up to day 106)
- Incidence of Treatment-Emergent Adverse Events [Safety](up to day 106)
- Pharmacokinetic Outcome Measures [AUC0-t](up to day 106)
- Pharmacokinetic Outcome Measures [Vd/F](up to day 106)
- Immunogenicity(up to day 106)
- Pharmacokinetic Outcome Measures [t1/2](up to day 106)
- Pharmacodynamics [IgE levels](up to day 106)
研究者
研究点 (1)
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