[Translation] Evaluation of AP017 monoclonal antibody injection in healthy subjects in a randomized, double-blind, placebo
Safety, tolerability and pharmacokinetics of parallel-dose, dose-escalating single administration
phase I clinical study
主要目的
评价健康受试者单次注射不同剂量AP017单克隆抗体注射液的安全性和耐受
性。
次要目的
1)评价健康受试者单次注射不同剂量AP017单克隆抗体注射液的药代动力学
特征;
2)评价健康受试者单次注射不同剂量AP017单克隆抗体注射液的免疫原性;
3)评价健康受试者单次注射不同剂量AP017单克隆抗体注射液的药效学特
征。
探索性目的
探索健康受试者单次注射不同剂量AP017单克隆抗体注射液的PK/PD相关性。
[Translation] main purpose
To evaluate the safety and tolerance of single injection of different doses of AP017 monoclonal antibody injection in healthy subjects
sex.
secondary purpose
1) Evaluate the pharmacokinetics of single injection of different doses of AP017 monoclonal antibody injection in healthy subjects
feature;
2) Evaluate the immunogenicity of a single injection of different doses of AP017 monoclonal antibody injection in healthy subjects;
3) To evaluate the pharmacodynamic characteristics of a single injection of different doses of AP017 monoclonal antibody injection in healthy subjects
sign.
exploratory purpose
To explore the PK/PD correlation of single injection of different doses of AP017 monoclonal antibody injection in healthy subjects.