Safety, Tolerability, Pharmacokinetics(PK), Pharmacodynamics(PD) and Food Effect of HRS9950 in Healthy and CHB Subjects

• Status: Not yet recruiting
• Trial end date: 2022-03-30

Summary

The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS9950. The study will be conducted in three parts sequentially:

Part 1, evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of single and multiple doses of HRS9950 tablet in healthy subjects. Part 1 will consist of 64 healthy subjects, 6 groups.

Part 2, evaluate food effect of HRS9950 in healthy subjects. Part 2 will consist of 14 healthy subjects, 1 group (one of groups in Part 1).

Part 3, evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of multiple doses of HRS9950 tablet in naïve and treatment-experienced chronic hepatitis B (CHB) patients. Part 3 will consist of 40 CHB patients, 1 group for naïve patients and 3 groups for treatment-experienced patients.

• Phase: Phase 1

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.