The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057 100 mg/mL and Humira 100 mg/mL, in healthy subjects. The study is conducted in a population of healthy male subjects aged 18-45 years inclusive at the time of signing the ICF, with a body mass index in the range of 18.5 to 30.0 kg/m2.
Signing the Informed Consent Form of the study.
Men aged 18-45 years inclusive at the time of signing the Informed Consent Form.
Body mass index (BMI) in the range of 18.5-30.0 kg/m2.
The confirmed "healthy" status based on the conventional clinical and laboratory assessments and investigations obtained as screening.
Mental illness or other conditions that may, in the Investigator's opinion, affect the subject's ability to comply with the Study Protocol.
Any significant, in the Investigator's opinion, surgical procedures performed less than 30 days before the screening examination and potentially affecting clinical study results.
A history of allergic reactions (anaphylactic shock or multiple drug allergy according to the Investigator's assessment).
Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the IP.
Parallel
Adalimumab (BCD-057) 100 mg/mL
DrugSingle subcutaneous injection
Adalimumab (BCD-057) 50 mg/mL
DrugSingle subcutaneous injection
Adalimumab (Humira) 100 mg/mL
DrugSingle subcutaneous injection
AUC(0-∞)
Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity
Cmax
Maximum Concentration
AUC(0-1680)
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours
Tmax
Time to Reach Maximum Concentration
T½
Half-life Period
Vd
Volume of Distribution
