[Translation] A phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of a recombinant human C1 esterase inhibitor for injection in patients with hereditary angioedema
主要目的:评价不同剂量注射用重组人C1酯酶抑制剂在HAE无症状患者中的安全性和耐受性;
次要目的:评价不同剂量注射用重组人C1酯酶抑制剂在HAE无症状患者中的药代动力学、药效学特征和免疫原性。
[Translation] Primary objective: To evaluate the safety and tolerability of different doses of recombinant human C1 esterase inhibitor for injection in asymptomatic HAE patients;
Secondary objective: To evaluate the pharmacokinetics, pharmacodynamic characteristics and immunogenicity of different doses of recombinant human C1 esterase inhibitor for injection in asymptomatic HAE patients.