Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection
* Drug: adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: monoclonal antibody injection<br>human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection 40mg administered subcutaneously once | Drug: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection<br>* human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once<br>|
| Active Comparator: adalimumab<br>adalimumab 40mg administered subcutaneously once | Drug: adalimumab<br>* adalimumab, 40mg,subcutaneous injection,once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast) |  | 71days | 
| Area under the concentration-time curve from time zero to infinity(AUCinf) |  | 71days | 
| Maximum serum concentration(Cmax) |  | 71days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach the maximum concentration(Tmax) |  | 71days | 
| Elimination rate constant(γz) |  | 71days | 
| Terminal half-live(T1/2) |  | 71days | 
| Apparent clearance(CL/F) |  | 71days | 
| Apparent volume of distribution(V/F) |  | 71days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor necrosis factor-a blocker, pharmacokinetics, safety