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Clinical Trials associated with Interferon alfa-2b biosimilar(Changchun Institute of Biological Products)原液工艺变更后人干扰素α2b注射液和注射用人干扰素α2b两制剂在健康受试者中的PK/PD比较研究
[Translation] Comparative PK/PD study of human interferon α2b injection and human interferon α2b for injection after the original solution process was changed in healthy subjects
(1)主要目的:比较原液变更后人干扰素α2b注射液和注射用人干扰素α2b在健康受试者的PK/PD是否存在差异。
(2)次要目的:评价人干扰素α2b注射液在健康受试者中的安全性,初步探索免疫原性。
[Translation] (1) Primary objective: To compare whether there are differences in PK/PD between human interferon α2b injection and human interferon α2b for injection in healthy subjects after the stock solution is changed.
(2) Secondary objective: To evaluate the safety of human interferon α2b injection in healthy subjects and preliminarily explore the immunogenicity.
重组人干扰素 α2b 注射液和注射用重组人干扰素 α2b 在健康受试者中的 PK/PD 比较研究
[Translation] Comparative PK/PD study of recombinant human interferon α2b injection and recombinant human interferon α2b for injection in healthy subjects
主要目的:比较重组人干扰素α2b注射液和注射用重组人干扰素α2b在健康受试者的PK/PD是否存在差异,为下一步临床研究提供依据。 次要目的:评价重组人干扰素α2b注射液在健康受试者中的安全性。
[Translation] Primary objective: To compare whether there are differences in PK/PD between recombinant human interferon α2b injection and recombinant human interferon α2b for injection in healthy subjects, and to provide a basis for the next clinical study. Secondary objective: To evaluate the safety of recombinant human interferon α2b injection in healthy subjects.
100 Clinical Results associated with Interferon alfa-2b biosimilar(Changchun Institute of Biological Products)
100 Translational Medicine associated with Interferon alfa-2b biosimilar(Changchun Institute of Biological Products)
100 Patents (Medical) associated with Interferon alfa-2b biosimilar(Changchun Institute of Biological Products)
100 Deals associated with Interferon alfa-2b biosimilar(Changchun Institute of Biological Products)