[Translation] A Phase I clinical study evaluating the safety, tolerability, and pharmacokinetics of YKYY013 in healthy volunteers with a single dose, and the safety, tolerability, pharmacokinetics, and preliminary efficacy of YKYY013 with multiple doses in patients with chronic hepatitis B virus infection.
主要目的:
评估 YKYY013 在健康志愿者和在慢性乙型肝炎病毒(HBV)感染患者中的安全性和耐受性。
次要目的:
1) 评估 YKYY013 在健康志愿者和在慢性 HBV 感染患者中的药代动力学(PK)特征;
2) 评估 YKYY013 在慢性 HBV 感染患者中的初步疗效;
3) 评估 YKYY013 在健康志愿者和在慢性 HBV 感染患者中的免疫原性。
探索性目的:
1) 评估 YKYY013 在健康志愿者中的血药浓度对 QTc 间期的影响。
2) 评估 YKYY013 在慢性 HBV 感染患者中的药效学(PD)特征。
[Translation] Primary Objective:
Evaluate the safety and tolerability of YKYY013 in healthy volunteers and patients with chronic hepatitis B virus (HBV) infection.
Secondary Objectives:
1) Evaluate the pharmacokinetic (PK) characteristics of YKYY013 in healthy volunteers and patients with chronic HBV infection;
2) Evaluate the preliminary efficacy of YKYY013 in patients with chronic HBV infection;
3) Evaluate the immunogenicity of YKYY013 in healthy volunteers and patients with chronic HBV infection.
Exploratory Objectives:
1) Evaluate the effect of YKYY013 plasma concentrations on the QTc interval in healthy volunteers;
2) Evaluate the pharmacodynamic (PD) characteristics of YKYY013 in patients with chronic HBV infection.