[Translation] A randomized, double-blind, placebo-controlled phase Ia clinical study evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of a single subcutaneous administration of CA111 injection in healthy adult male participants in China.
主要目的:评估CA111注射液在中国健康成年男性试验参与者中单次给药的安全性、耐受性。
次要目的:评估CA111注射液在中国健康成年男性试验参与者中单次给药的药代动力学(PK)特征;评估CA111注射液在中国健康成年男性试验参与者中单次给药的药效学(PD)特征;评估CA111注射液在中国健康成年男性试验参与者中单次给药的免疫原性特征。
探索性目的:初步评价CA111注射液在中国健康成年男性试验参与者中单次给药后的血药浓度与QTc间期的关系。
[Translation] Primary objective: To evaluate the safety and tolerability of a single-dose CA111 injection in healthy adult male participants in China.
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of a single-dose CA111 injection in healthy adult male participants in China; to evaluate the pharmacodynamic (PD) characteristics of a single-dose CA111 injection in healthy adult male participants in China; to evaluate the immunogenicity of a single-dose CA111 injection in healthy adult male participants in China.
Exploratory objective: To preliminarily evaluate the relationship between plasma concentration and QTc interval after a single-dose CA111 injection in healthy adult male participants in China.