A randomized, double-blind, single-dose, two-way, parallel phase I clinical study comparing the pharmacokinetics and safety of adalimumab injecta and Humira® in healthy Chinese male volunteers.

BACKGROUND: Humira® is a fully humanized anti-tumor necrosis factor (TNF-α) monoclonal antibody that has been marketed and approved in the United States for the clinical treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis and other immune-mediated diseases. This study compared the bioequivalence, immunogenicity and safety of adalimumab injecta (a biosimilar of Humira® produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd) and Humira® in healthy Chinese male subjects in a phase I clinical study. METHODS: Healthy Chinese male subjects (N = 164) were randomly given a subcutaneous injection of 40 mg adalimumab or Humira® at a 1:1 ratio. Plasma drug concentrations were detected by enzyme-linked immunosorbent assay (ELISA), and primary pharmacokinetic (PK) parameters were statistically analyzed. To evaluate drug immunogenicity, anti-drug antibody (ADA) and neutralizing antibody (nAb) levels were detected. To evaluate the safety of the drugs, the subjects' physical indicators, such as multiple vital signs and routine blood tests, were continuously monitored. RESULTS: The similarity ratios of adalimumab and Humira® PK parameters were all within 80%-125%, meeting the bioequivalence standards. Drug-induced ADA and nAb levels were similar, and the drug safety in subjects was also similar. CONCLUSIONS: All study drugs showed similar bioequivalence, immunogenicity and safety. CLINICAL TRIAL REGISTRATION: CTR20182070 (Chinese Clinical Trial Registry).