[Translation] A randomized, double-blind, placebo-controlled, single-ascending dose clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of STSA-1201 subcutaneous injection in healthy subjects
主要目的
(1)评价STSA-1201单次皮下给药在健康受试者中的安全性和耐受性。
(2)探索STSA-1201单次皮下给药在健康受试者中的药代动力学特征。
次要目的
评价STSA-1201单次皮下给药在健康受试者中的免疫原性特征。
探索性目的
探索STSA-1201单次皮下给药对健康受试者中的血免疫球蛋白E(IgE)、外周血嗜酸性粒细胞计数和百分比、IL-4、IL-5、IL-13的影响。
[Translation] Primary objectives
(1) To evaluate the safety and tolerability of a single subcutaneous administration of STSA-1201 in healthy subjects.
(2) To explore the pharmacokinetic characteristics of a single subcutaneous administration of STSA-1201 in healthy subjects.
Secondary objectives
To evaluate the immunogenicity characteristics of a single subcutaneous administration of STSA-1201 in healthy subjects.
Exploratory objectives
To explore the effects of a single subcutaneous administration of STSA-1201 on blood immunoglobulin E (IgE), peripheral blood eosinophil counts and percentages, IL-4, IL-5, and IL-13 in healthy subjects.