CompletedPhase 1

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

China146 participantsStarted 2020-07-20

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent.
✓. Aged 18\~55.
✓. 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.
✓. Signed informed consent.
✓. Aged 18\~65.
✓. CHB subjects should meet the following two criteria:

Exclusion criteria

✕. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
✕. Medical history of malignant tumor.

What they're measuring

The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0

Timeframe: 8 DAYS for Group A-M; 29 DAYS for Group F; 50 DAYS for Group G-O

Maximum Plasma Concentration [Cmax]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22

Area under the concentration time curve [AUC]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22

Time to maximum plasma concentration [Tmax]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22

Apparent clearance [CL/F]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22

Half-time [t1/2]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22

Apparent volume of distribution [Vz/F（Vd）]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22

Trial details

NCT IDNCT04464733

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-30

View on ClinicalTrials.gov More Chronic Hepatitis b trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent.
✓. Aged 18\~55.
✓. 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.
✓. Signed informed consent.
✓. Aged 18\~65.
✓. CHB subjects should meet the following two criteria:

Exclusion criteria

✕. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
✕. Medical history of malignant tumor.

What they're measuring

The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0

Timeframe: 8 DAYS for Group A-M; 29 DAYS for Group F; 50 DAYS for Group G-O

Maximum Plasma Concentration [Cmax]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22

Area under the concentration time curve [AUC]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22

Time to maximum plasma concentration [Tmax]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 1 and Day 22

Apparent clearance [CL/F]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22

Half-time [t1/2]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22

Apparent volume of distribution [Vz/F（Vd）]

Timeframe: 0-48 hours after each dose for Group A-E、K-M；Group F- J、N、O at Day 22