[Translation] A single-center, randomized, double-blind, placebo-controlled phase Ia clinical study evaluating the safety, tolerability, and pharmacokinetics of a single subcutaneous injection of JY54 in healthy participants.
主要研究目的:
评价健康参与者接受JY54注射液单次给药后的安全性和耐受性。
次要研究目的:
评价健康参与者接受JY54注射液单次给药后的药代动力学(Pharmacokinetics, PK)特征。
评价健康参与者接受JY54注射液单次给药后的免疫原性。
探索性研究目的:
探索健康参与者接受JY54注射液单次给药后的药效学(Pharmacodynamic, PD)指标较基线的变化。
[Translation] Primary Study Objective: To evaluate the safety and tolerability of a single dose of JY54 injection in healthy participants.
Secondary Study Objective: To evaluate the pharmacokinetic (PK) characteristics of a single dose of JY54 injection in healthy participants.
To evaluate the immunogenicity of a single dose of JY54 injection in healthy participants.
Exploratory Study Objective: To investigate the changes in pharmacodynamic (PD) parameters from baseline after a single dose of JY54 injection in healthy participants.