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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
183
human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once
adalimumab, 40mg,subcutaneous injection,once
Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast)
Time frame: 71days
Area under the concentration-time curve from time zero to infinity(AUCinf)
Time frame: 71days
Maximum serum concentration(Cmax)
Time frame: 71days
Time to reach the maximum concentration(Tmax)
Time frame: 71days
Elimination rate constant(γz)
Time frame: 71days
Terminal half-live(T1/2)
Time frame: 71days
Apparent clearance(CL/F)
Time frame: 71days
Apparent volume of distribution(V/F)
Time frame: 71days
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