[Translation] A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered BW-00163 in healthy Chinese subjects
本研究的主要目的是评估中国健康受试者单次皮下给药BW-00163 的安全性和耐受性。
本研究的次要目的是评估BW-00163 及其代谢物的药代动力学(PK)及评估BW-00163 对血清血管紧张素原(AGT)水平的药效学(PD)影响
本研究的探索目的是评估BW-00163 对收缩压(SBP)和舒张压(DBP)的影响、评估BW-00163 对肾素-血管紧张素-醛固酮系统(RAAS)生物标志物的影响及评估BW-00163 的免疫原性
[Translation] The primary objective of this study is to evaluate the safety and tolerability of a single subcutaneous administration of BW-00163 in healthy Chinese subjects.
The secondary objectives of this study are to evaluate the pharmacokinetics (PK) of BW-00163 and its metabolites and to evaluate the pharmacodynamic (PD) effects of BW-00163 on serum angiotensinogen (AGT) levels
The exploratory objectives of this study are to evaluate the effects of BW-00163 on systolic blood pressure (SBP) and diastolic blood pressure (DBP), to evaluate the effects of BW-00163 on renin-angiotensin-aldosterone system (RAAS) biomarkers and to evaluate the immunogenicity of BW-00163