[Translation] A randomized, double-blind, placebo-controlled, single-dose escalation phase I clinical study of the tolerability, safety, pharmacokinetics and immunogenicity of AS1501 for injection in healthy Chinese subjects
主要目的:
评价注射用AS1501在中国健康受试者中单次静脉注射给药的耐受性和安全性,为后期临床研究推荐合理的给药方案;
次要目的:
(1)评价注射用AS1501在中国健康受试者中的药代动力学特征;
(2)评价注射用AS1501在中国健康受试者中的免疫原性;
探索性目的:
初步探索注射用AS1501静脉注射给药前后血清中TRAIL表达水平的变化。
[Translation] Main purpose:
To evaluate the tolerability and safety of a single intravenous injection of AS1501 for injection in healthy Chinese subjects, and to recommend a reasonable dosing regimen for later clinical studies;
Secondary purpose:
(1) To evaluate the pharmacokinetic characteristics of AS1501 for injection in healthy Chinese subjects;
(2) To evaluate the immunogenicity of AS1501 for injection in healthy Chinese subjects;
Exploratory purpose:
To preliminarily explore the changes in serum TRAIL expression levels before and after intravenous injection of AS1501 for injection.