This is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects.
It is planned to enroll 198 male subjects in this study. Eligible subjects will be randomized into 2 dosing groups at 1:1 (GLR1044 group or Dupilumab group), i.e., 99 subjects in each group. Each subject is administered once by subcutaneous injection in the abdomen, during which the subject is required to be hospitalized for 4 days. The safety follow-up will last until D57.
1.Voluntarily sign the informed consent form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
1.History of drug abuse within 1 year prior to screening, or positive predose drug abuse screening result at Visit 2 (V2); or history of alcohol abuse within 6 months prior to screening, or positive predose alcohol breath test result at V2.
Parallel
GLR1044 injection
DrugGLR1044 injection 300mg/2.0mL; subcutaneous injection; single dose
Dupilumab Injection
DrugDupilumab Injection 300mg/2.0mL; subcutaneous injection; single dose
Pharmacokinetic indicators:Cmax
Pharmacokinetic indicators:AUC0-∞.
Pharmacokinetic indicators: AUC0-t
Pharmacokinetic indicators: CL
Pharmacokinetic indicators: λz
Pharmacokinetic indicators: Tmax
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This trial is not recruiting at the moment. You can still explore other options:
