It is a randomized, double-blinded, parallel, single-dose, PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent® in healthy Chinese adult subjects. A total of 198 healthy subjects are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml QL2108 injection or Dupixent®.
The study has a screening period of 28 days. PK blood samples will be collected from subjects to determine the serum concentration of Dupilumab, thus to evaluate the similarity of the pharmacokinetics of the two study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
Jinan Central Hospital
Jinan, Shandong, China
Pharmacokinetics Endpoint
Cmax
Time frame: 0-8weeks
Pharmacokinetics Endpoint
AUC0-∞
Time frame: 0-8weeks
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