Semaglutide Biosimilar(Huadong Medicine/Chongqing Peg-Bio Biopharma)

评价在健康成年受试者中单次皮下注射杭州中美华东制药江东有限公司生产的司美格鲁肽注射液和丹麦诺和诺德公司生产的诺和泰®注射液的AUC0-inf、AUC0-t和Cmax的相似性。

This study is a randomized, open-label, single-dose, parallel-controlled biosimilar comparison study comparing the pharmacokinetics, safety and immunogenicity of the investigational drug and the active comparator in healthy adult subjects. Eligible healthy participants will be screened and randomly assigned to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection 0.25mg abdominal subcutaneous injection will be given according to their groups. Follow-up for 5 weeks after administrtion.
Studies included a screening period (up to 2 weeks), baseline, administration (single dose), and a follow-up period (5 weeks). The duration of the study will be approximately 7 weeks for a participant.