NCT04480294

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B Patients

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics of Oral HRS5091 in Healthy Subjects With Single or Multiple Dose and Chronic Hepatitis B Patients With Multiple Dose, and Food Effects of HRS5091 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS5091. The study will be conducted in three parts sequentially: Part 1a will consist of 58 healthy subjects, 5 groups. The purpose of this part is to explore the safety, tolerability and pharmacokinetics of single doses of HRS5091 tablet in healthy subjects. Part 1b will consist of 18 healthy subjects and it is one of groups in Part 1a.The purpose of this part is to explore food effect of HRS5091 in healthy subjects. Part 1c will consist of 10 healthy subjects, 1 groups. The purpose of this part is to explore the safety, tolerability and pharmacokinetics of multiple doses of HRS5091 tablet in healthy subjects. Part 2 will consist of 30 CHB patients.The purpose of this part is to explore the safety, tolerability and pharmacokinetics, pharmacodynamics of multiple doses of HRS5091 tablet in naïve and treatment-discontinued chronic hepatitis B (CHB) patients.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	HRS5091	Single dose in group 1-5 Multiple doses in group 6-9

Timeline

• Start date: 2020-07-28
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2020-07-21
• Last updated: 2021-10-22

Locations

1 site across 1 country: China