[Translation] A randomized, double-blind, dose-escalation, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of HRS-7249 injection in healthy subjects
主要目的:评估单次皮下注射HRS-7249注射液在健康受试者中的安全性和耐受性。
次要目的:描述单次皮下注射HRS-7249注射液在健康受试者体内的药代动力学(PK)和药效学(PD)特征;评估单次皮下注射HRS-7249注射液在健康受试者体内的免疫原性;血浆、尿液中HRS-7249的代谢物谱;评估HRS-7249对QT/QTc的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of a single subcutaneous injection of HRS-7249 injection in healthy subjects.
Secondary objectives: To describe the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of a single subcutaneous injection of HRS-7249 injection in healthy subjects; to evaluate the immunogenicity of a single subcutaneous injection of HRS-7249 injection in healthy subjects; the metabolite profile of HRS-7249 in plasma and urine; and to evaluate the effect of HRS-7249 on QT/QTc.