[Translation] Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects: a randomized, double-blind, dose-escalation, placebo-controlled phase I clinical trial
主要研究目的:评估单次静脉/皮下注射SHR-2010在健康受试者中的安全性、耐受性。
次要研究目的:描述单次静脉/皮下注射SHR-2010在健康受试者中的药代动力学(PK)特征;描述单次静脉/皮下注射SHR-2010在健康受试者中的药效动力学(PD)特征;评估单次静脉/皮下注射SHR-2010在健康受试者体内的免疫原性。
[Translation] Primary study objectives: To evaluate the safety and tolerability of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects.
Secondary study objectives: To describe the pharmacokinetic (PK) characteristics of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects; To describe the pharmacodynamic (PD) characteristics of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects; To evaluate the immunogenicity of a single intravenous/subcutaneous injection of SHR-2010 in healthy subjects.