[Translation] Phase I clinical study of the safety, tolerability, and pharmacokinetic characteristics of HRS-5635 injection after a single dose in Chinese healthy subjects and the safety, tolerability, pharmacokinetics, and antiviral effects of multiple doses in patients with chronic hepatitis B
主要研究目的:
评价HRS-5635单次给药在健康受试者中安全性与耐受性;评价HRS-5635多次给药在慢性乙型肝炎患者中安全性与耐受性。
次要研究目的: 评价HRS-5635单次给药在健康受试者中药代动力学特征和免疫原性;评价HRS-5635多次给药在慢性乙型肝炎患者中药代动力学特征和免疫原性;评价HRS-5635多次给药在慢性乙型肝炎患者中的抗病毒作用。
[Translation] Main study objectives:
To evaluate the safety and tolerability of HRS-5635 after a single dose in healthy subjects; To evaluate the safety and tolerability of HRS-5635 after multiple doses in patients with chronic hepatitis B.
Secondary study objectives: To evaluate the pharmacokinetic characteristics and immunogenicity of HRS-5635 after a single dose in healthy subjects; To evaluate the pharmacokinetic characteristics and immunogenicity of HRS-5635 after multiple doses in patients with chronic hepatitis B; To evaluate the antiviral effect of HRS-5635 after multiple doses in patients with chronic hepatitis B.