[Translation] First-in-human, randomized, double-blind, placebo study of BG136 for injection in healthy subjects
Controlled, single-dose-escalation and multiple-dose-escalation phase I trials
主要目的:
评估注射用BG136在健康受试者中单次和多次静脉滴注给药的安全性和耐受性。
次要目的:
评估健康受试者单次和多次静脉滴注注射用BG136的药代动力学(PK)和药效动力学(PD)特征;
评估注射用BG136在健康受试者体内安全有效的剂量范围,为Ⅱ期临床研究的给药方案提供依据;
评估注射用BG136在健康受试者体内免疫原性。
[Translation] main purpose:
To evaluate the safety and tolerability of single and multiple intravenous infusions of BG136 for injection in healthy subjects.
Secondary purpose:
To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single and multiple intravenous infusions of BG136 for injection in healthy subjects;
Evaluate the safe and effective dose range of BG136 for injection in healthy subjects, and provide a basis for the dosing regimen of phase II clinical research;
To evaluate the immunogenicity of BG136 for injection in healthy subjects.