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Safety, Tolerability, Pharmacokinetics(PK), Pharmacodynamics(PD) and Food Effect of HRS9950 in Healthy and CHB Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase I Study to Evaluate the Safety, Tolerability and PK, PD of Oral HRS9950 in Healthy Subjects With Single or Multiple Dose and Chronic Hepatitis B Patients With Multiple Dose, and Food Effects of HRS9950 in Healthy Subjects

NCT04464733•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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 doses and multiple dose of HRS9950 tablet in healthy subjects. Part 1 will consist of 84 healthy subjects, 8 groups.There will be 14 subjects in 0.75mg dose group,10 subjects in each other dose group . 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 naive and treatment-experienced chronic hepatitis B (CHB) patients. Part 3 will consist of 60 CHB patients, 1 group for naive patients and 5 groups for treatment-experienced patients.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy subjects
•1. Signed informed consent.
•2. Aged 18\~55.
•3. Body weight ≥ 50 kg for male; ≥ 45 kg for female, body mass index (BMI) between 18 to 28 kg/m2.
•4. Vital signs, physical examination, laboratory results are within normal range or considered not clinically significant.
•5. Female subjects (including partner) of childbearing potential must be using a medically acceptable form of birth control.
•CHB subjects
•1. Signed informed consent.
•2. Aged 18\~65.
•3. CHB subjects should meet the following two criteria:
+11 more criteria

Exclusion Criteria

•Healthy subjects
•1. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
•2. Medical history of malignant tumor.
•3. Have a digestive system disease or a medical history of severe digestive system disease.
•4. Have severe infection, severe trauma or major surgical operations within 3 months.
•5. 12-ECG test have clinical significant abnormality or the QT interval (QTc) \> 450 ms.
•6. Clinical laboratory examinations or chest radiographs have clinical significant abnormality.
•7. Have a medical history of immune-mediated diseases.
•8. Screening for infectious diseases is positive (Including HBsAg, Anti-HCV, TPPA, Anti-HIV).
•9. Suspected allergy to any ingredient in the study drug.
+33 more criteria

Locations (1)

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

July 20, 2020

Primary Completion Date

May 30, 2023

Completion Date

May 30, 2023

Last Updated

November 5, 2024

Enrollment

146

ACTUAL participants

Conditions

Chronic Hepatitis b

Interventions

HRS9950

DRUG

Placebo

DRUG

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Chronic Hep BChronic Hepatitis b+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

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