[Translation] A randomized, double-blind, parallel-design exploratory clinical study to evaluate the safety, pharmacodynamics and pharmacokinetic characteristics of multiple subcutaneous injections of LP-98 in HIV-infected patients who have not received antiviral treatment
主要目的:评估在未接受过抗病毒治疗的HIV感染者中多次皮下注射LP-98后的安全性和耐受性。次要目的:评估在未接受过抗病毒治疗的HIV感染者中多次皮下注射LP-98后的药效(PD)作用。评估在未接受过抗病毒治疗的HIV感染者中多次皮下注射LP-98后的药代动力学(PK)特征。评估在未接受过抗病毒治疗的HIV感染者中多次皮下注射LP-98后的免疫原性。探索性目的:探索在未接受过抗病毒治疗的HIV感染者中多次皮下注射LP-98后的病毒学治疗失败的情况。
[Translation] Primary objective: To evaluate the safety and tolerability of LP-98 after multiple subcutaneous injections in HIV-infected individuals who have not received antiviral treatment. Secondary objectives: To evaluate the pharmacodynamic (PD) effect of LP-98 after multiple subcutaneous injections in HIV-infected individuals who have not received antiviral treatment. To evaluate the pharmacokinetic (PK) characteristics of LP-98 after multiple subcutaneous injections in HIV-infected individuals who have not received antiviral treatment. To evaluate the immunogenicity of LP-98 after multiple subcutaneous injections in HIV-infected individuals who have not received antiviral treatment. Exploratory objectives: To explore the failure of virological treatment after multiple subcutaneous injections of LP-98 in HIV-infected individuals who have not received antiviral treatment.