[Translation] Phase I study on the safety, tolerability, pharmacokinetics, and food effects of single and multiple oral administration of HRS9950 tablets in healthy subjects and multiple oral administration in patients with chronic hepatitis B
主要目的: 1. HRS9950 单次和多次给药在健康人中的安全性与耐受性; 2.食物对药代、药动学的影响; 3.多次给药在慢乙肝患者中的安全性与耐受性。 次要目的: 1.单次和多次给药的药动学; 2.食物影响对健康人的安全性与耐受性; 3.单次和多次给药的药动学。 探索性目的: 1.多次给药在慢乙型肝炎患者中的病毒学指标。
[Translation] Primary objectives: 1. Safety and tolerability of single and multiple doses of HRS9950 in healthy people; 2. Effects of food on pharmacokinetics and pharmacokinetics; 3. Safety and tolerability of multiple doses in patients with chronic hepatitis B. Secondary objectives: 1. Pharmacokinetics of single and multiple doses; 2. Food effects on safety and tolerability in healthy people; 3. Pharmacokinetics of single and multiple doses. Exploratory objectives: 1. Virological indicators of multiple doses in patients with chronic hepatitis B.