Dataset from A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis
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下载链接:
https://doi.org/10.25934/00007188
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资源简介:
The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield
Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the
pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS).
The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC
HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of
participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for
cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).
创建时间:
2025-06-30



