[Translation] A randomized, double-blind, parallel-controlled, single-dose pharmacokinetic study of recombinant anti-TNFα fully human monoclonal antibody injection and adalimumab injection (Humira®) in healthy subjects
主要试验目的:比较重组抗TNFα全人源单克隆抗体注射液与原研药Adalimumab(Humira®)在健康受试者中单次皮下注射给药的药代动力学特征,为后期临床试验设计提供依据。
次要试验目的:观察重组抗TNFα全人源单克隆抗体注射液与原研药Adalimumab(Humira®)在健康受试者中的安全性。
[Translation] The main purpose of the trial is to compare the pharmacokinetic characteristics of a single subcutaneous injection of a recombinant anti-TNFα fully human monoclonal antibody injection and the original drug Adalimumab (Humira®) in healthy subjects, and to provide a basis for the design of later clinical trials.
The secondary purpose of the trial is to observe the safety of a recombinant anti-TNFα fully human monoclonal antibody injection and the original drug Adalimumab (Humira®) in healthy subjects.