The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
160
Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.
Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.
Beijing Gaobo Boren Hosipital
Beijing, Beijing Municipality, China
AUC0-t
Area under the plasma concentration-time curve
Time frame: From pre-dose to day 85
Cmax
concentration
Time frame: From pre-dose to day 85
AUC0-infinity
Area under the plasma concentration-time curve
Time frame: From pre-dose to day 85
Tmax
Time to maximum concentration
Time frame: From pre-dose to day 85
CL
Clearance
Time frame: From pre-dose to day 85
λz
Apparent terminal elimination rate constant
Time frame: From pre-dose to day 85
t1/2
Half-life (
Time frame: From pre-dose to day 85
Vd
Volume of distribution
Time frame: From pre-dose to day 85
Safety and tolerance
Adverse events (AE)
Time frame: From pre-dose to day 85
Immunogenicity assessment
Anti-drug Antibody (ADA)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From pre-dose to day 85