A Open, Randomized, Single-dose, Comparative Bioequivalency and Safety Study of Human Recombinant Anti-tumor Necrosis Factor Alpha Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 183
- 主要终点
- Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast)
研究概览
简要总结
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used as a single subcutaneous injection in healthy volunteers.
详细描述
This is a comparative, open, randomized clinical study. The purpose of the study is to demonstrate that human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection is equivalent to adalimumab in terms of pharmacokinetics and safety after single subcutaneous injection in Chinese healthy volunteers.The study will enroll 180 healthy volunteers, who will be randomized into 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, age between 18 and 55;
- •Body weight≥50kg and body mass index(BMI) within the range 19 to 28 kg/m2;
- •To fully understanding the purpose of the study, to understand the pharmacological action of the study drugs and the possible adverse reactions; participants who are voluntary to sign the informed consent according to the Declaration of Helsinki.
排除标准
- •History of adalimumab treatment;
- •History of relevant allergy/hypersensitivity(including allergy to the study drug or its ingredient );
- •Participation in another interventional trial within 3 months prior to administration of the study drug;
- •Blood donation(more than 200 mL within 12 weeks prior to administration of the study drug);
- •Use of any drugs(including traditional Chinese medicine) within 2 weeks or at least 5 half-lives(whichever is longer) prior to administration;
- •History of cluster of differentiation 4 antagonist or tumor necrosis factor alpha antagonist use, or use tumor necrosis factor antagonist(such as thalidomide) 3 months prior to administration;
- •Abnormal significant clinically chest radiograph, ECG, or laboratory examinations at screening and Baseline, judged by the investigators;
- •History of opportunistic infection(s)(such as: herpes zoster, mycoplasma, Pneumocystis carinii, histoplasma, Aspergillus, mycobacterium) within 6 months prior to screening;
- •Known recurrent or chronic infectious disease(s) history, including but not limited to: chronic kidney infect, chronic chest infection(such as bronchiectasis), nasosinusitis, recurrent urinary tract infection, open, drainage or infected wounds of the skin;
- •Tuberculosis(TB) history, or suspected clinically TB(including but not limited to: pulmonary tuberculosis, lymphoid tuberculosis, tuberculous pleurisy), or a positive Tuberculosis spot test;
- •Positive serology for human immunodeficiency virus(HIV) antibody;
- •Positive serology for hepatitis C virus antibody;
- •Active or chronic hepatitis B virus infection, such as positive hepatitis B virus surface antigen;
- •History of organ transplant(except for corneal transplantation≥3 months prior to Screening);
- •Known immunodeficiency history;
- •Use a live vaccine within 3 months prior to administration;
- •Alcohol or drug abuse within 12 months prior to Screening; unwilling/inability to refrain from alcohol from 72 hours prior to administration and until during the trial period;
- •Unwilling to use adequate contraception(such as condoms) during the study period;
- •Evidence suggests presence of clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, hematologic, or neurologic abnormality;
- •Mentally impaired;
- •Disabilities, bed rest, wheelchair dependent, or lack of activity of daily life;
- •Subjects who are unsuited to the study for any reason, judged by the investigators.
研究组 & 干预措施
monoclonal antibody injection
human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection 40mg administered subcutaneously once
干预措施: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection (Drug)
adalimumab
adalimumab 40mg administered subcutaneously once
干预措施: adalimumab (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast)
时间窗: 71days
Area under the concentration-time curve from time zero to infinity(AUCinf)
时间窗: 71days
Maximum serum concentration(Cmax)
时间窗: 71days
次要结局
- Apparent clearance(CL/F)(71days)
- Time to reach the maximum concentration(Tmax)(71days)
- Elimination rate constant(γz)(71days)
- Terminal half-live(T1/2)(71days)
- Apparent volume of distribution(V/F)(71days)