[Translation] A multicenter, open-label study evaluating the safety, pharmacokinetics, and efficacy of lanallimumab (SHP643) in Chinese subjects with hereditary angioedema
主要目的
本研究的主要目的是在中国HAE受试者中评价拉那利尤单抗重复皮下注射的安全性。 次要目的
本研究的次要目的为:
在中国HAE受试者中评价拉那利尤单抗重复皮下给药的PK。
在中国HAE受试者中评价拉那利尤单抗重复皮下给药的PD。
在中国HAE受试者中评价拉那利尤单抗重复皮下给药的疗效。
评估拉那利尤单抗重复皮下给药的免疫原性,以及对拉那利尤单抗的PK、PD、疗效和安全性的影响。
[Translation] main purpose
The primary objective of this study was to evaluate the safety of repeated subcutaneous injections of lanalizumab in Chinese HAE subjects. secondary purpose
The secondary objectives of this study are:
The PK of repeated subcutaneous administration of lanallimumab was evaluated in Chinese HAE subjects.
Evaluation of PD in Chinese HAE subjects with repeated subcutaneous administration of lanallimumab.
Efficacy of repeated subcutaneous administration of lanallimumab in Chinese HAE subjects.
To evaluate the immunogenicity of repeated subcutaneous dosing of lanalizumab and the impact on PK, PD, efficacy, and safety of lanalizumab.