Clinical Trials/NCT04480294

NCT04480294

Unknown

Phase 1

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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country108 target enrollmentJuly 28, 2020

ConditionsChronic Hepatitis B

InterventionsHRS5091

DrugsHRS5091

Overview

Phase: Phase 1
Intervention: HRS5091
Conditions: Chronic Hepatitis B
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 108
Locations: 1
Primary Endpoint: Maximum Plasma Concentration [Cmax]
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 28, 2020

End Date

November 23, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects
•Signed informed consent.
•Body weight ≥ 50 kg for male; ≥ 45 kg for female, body mass index (BMI) between 18 to 28 kg/m².
•Vital signs, physical examination, laboratory results are within normal range or considered not clinically significant.
•Female subjects (including partner) of childbearing potential must be using a medically acceptable form of birth control.
•CHB subjects
•Signed informed consent.
•CHB subjects should meet one of the following two criteria:
•IgM(immunoglobulin M) HBcAb negative and HBsAg positive.
•Two recorded HBsAg positive, and the time interval between the two tests was at least 6 months, one of which was the result of this screening

Exclusion Criteria

•Healthy subjects
•Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
•Have a digestive system disease or a medical history of severe digestive system disease at present or in the past month.
•Have severe infection, severe trauma or major surgical operations within 3 months. Plan to receive surgery during the trial and within two weeks after the end of the trial.
•12-ECG test have clinical significant abnormality or the QT interval (QTc) \> 470 ms(male)/QTc)\> 480 ms(male) or\<300ms(female).
•Have a medical history of immune-mediated diseases.
•Screening for infectious diseases is positive,Including HBsAg, Anti-HCV(hepatitis C virus), TPPA(Treponema pallidum particle agglutination assay), Anti-HIV.Treponema pallidum antibody screen positive, at the investigator's discretion in conjunction with RPR(rapid plasma reagin assay) results.
•Suspected allergy to any ingredient in the study drug.
•Have any drug that inhibits or induces liver metabolism within 1 month.
•Take any prescription drugs, over-the-counter drugs and Chinese herbal medicines within 14 days before taking the study drug, or plan to take other drugs during the test period.

Arms & Interventions

Part 1a Treatment group 1

Intervention: Drug1: HRS5091, dose 1; Drug2: Placebo Healthy subjects

Intervention: HRS5091

Part 1a Treatment group 2

Intervention: Drug1: HRS5091, dose 2; Drug2: Placebo Healthy subjects

Intervention: HRS5091

Part 1a Treatment group 3

Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects

Intervention: HRS5091

Part 1a Treatment group 4

Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo Healthy subjects

Intervention: HRS5091

Part 1a Treatment group 5

Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo Healthy subjects

Intervention: HRS5091

Part 1b Treatment group 3

Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects Food effect

Intervention: HRS5091

Part 1c Treatment group 6

Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects

Intervention: HRS5091

Part 2 Treatment group 7

Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo CHB subjects

Intervention: HRS5091

Part 2 Treatment group 8

Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo CHB subjects

Intervention: HRS5091

Part 2 Treatment group 9

Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo CHB subjects

Intervention: HRS5091