[Translation] A randomized, open-label, parallel phase I trial to investigate the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of QX029N injection in healthy subjects, and to compare the pharmacokinetic characteristics of QX029N injection with those of QX005N injection in healthy subjects
主要研究目的:
Part A:评估 QX029N 注射液与 QX005N 注射液的药代动力学(Pharmacokinetics,PK)特征。
Part B:评估450 mg 剂量 QX029N 注射液与 450 mg 剂量 QX005N在健康受试者中药物暴露水平的等效性。 次要研究目的:
Part A研究:评估 QX029N 注射液单次皮下注射给药的剂量-暴露关系;评估 QX029N 注射液单次皮下注射给药的安全性、耐受性;探索 QX029N 注射液在健康受试者的免疫原性和药效学(Pharmacodynamics,PD)特征;
Part B研究:评估 QX029N 注射液和 QX005N 注射液的 PK 特征;评估 QX029N 注射液和 QX005N 注射液的安全性;评估 QX029N 注射液和 QX005N 注射液在健康受试者的免疫原性
[Translation] Main study objectives:
Part A: To evaluate the pharmacokinetic (PK) characteristics of QX029N injection and QX005N injection.
Part B: To evaluate the equivalence of drug exposure levels between 450 mg dose of QX029N injection and 450 mg dose of QX005N in healthy subjects. Secondary study objectives:
Part A study: evaluate the dose-exposure relationship of QX029N injection after a single subcutaneous injection; evaluate the safety and tolerability of QX029N injection after a single subcutaneous injection; explore the immunogenicity and pharmacodynamics (PD) characteristics of QX029N injection in healthy subjects;
Part B study: evaluate the PK characteristics of QX029N injection and QX005N injection; evaluate the safety of QX029N injection and QX005N injection; evaluate the immunogenicity of QX029N injection and QX005N injection in healthy subjects