Chronic Hepatitis BPhase 1NCT04480294
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 1 study testing HRS5091 in people with Chronic Hepatitis B, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HRS5091
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2020to 23 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subjects
- 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.
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- CHB subjects
- Signed informed consent.
- Aged 18~65.
- 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
- CHB subjects should also meet the following criteria:
- No treatment with nucleosides analogues or discontinued treatment with nucleosides analogues least 6 months at screening
- Have not received interferon therapy or discontinued treatment with interferon analogues least 3 months at screening
- HBeAg positive，HBV(hepatitis B virus) DNA≥ 20000 IU/mL; HBeAg negative, HBV DNA≥ 2000 IU/mL
- ALT(Alanine aminotransferase)> 1 ULN(upper limit of normal) by two measurements within 6 months before enrollment.The interval between two measurements shall exceed 14 days;
- Female subjects (including partner) of childbearing potential must be using a medically acceptable form of birth control.
Who cannot join
- 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.
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- 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.
- Participated in clinical trials of any drug or medical device within 3 months before screening.
- Had donated blood/blood transfusion≥ 200 mL within 1 months prior to screening or donated blood or blood transfusion≥ 450 mL within 3 months prior to screening.
- The average daily smoking ≥ 5 cigarettes within three months; the average daily alcohol intake in a month exceeds 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol);
- Keep smoking, drinking alcohol or consuming caffeinated foods or beverages (more than 8 cups, 1 cup = 250 mL) 2 days before taking the study drug and during the study; and those who have special dietary requirements and cannot follow the unified diet;
- Pregnant or lactating women;
- Drug screening or alcohol breath test is positive.
- Other conditions that the investigator believes the subject is not suitable.
- CHB subjects
- Currently suffering from serious cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases other than hepatitis B.
- People have acute or chronic liver disease by non-HBV infection (Whether fatty liver is excluded or not is determined by the investigator).
- Liver stiffness (LSM)> 12.4 kPa(kilopascal) by noninvasive transient liver elastography (eg Fibroscan®) or recorded liver biopsy suggesting cirrhosis or extensive fibrosis within 6 months before randomization.
- Primary liver cancer, high-risk groups of primary liver cancer or AFP(alpha fetoprotein)> 50g/L;
- Have clinically demonstrated or history of liver function decompensation, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, splenomegaly, ascites, etc.;
- Laboratory inspection:
- Platelet count <90×10⁹/L;
- White blood cell count <3.0×10⁹/L;
- Absolute value of neutrophils <1.5×10⁹/L;
- Serum total bilirubin>2×ULN;
- Albumin <30 g/L;
- Creatinine clearance rate ≤60ml/min;
- INR(international normalized ratio)>1.5;
- ALT> 5 ULN on screening/baseline visit
- HIV and/or syphilis antibody positive (Treponema pallidum antibody screen positive, at the investigator's discretion in conjunction with RPR results).
- Subjects who have previously received organ/bone marrow transplantation;
- Have used immunosuppressants, immunomodulators or cytotoxic drugs within 6 months before the study medication;
- Suspected allergy to any ingredient in the study drug.
- 12-ECG test have clinical significant abnormality or the QT interval (QTc) > 470 ms(male)/QTc)> 480 ms(male) or<300ms(female).
- The average daily smoking ≥ 5 cigarettes within three months; the average daily alcohol intake in a month exceeds 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol);
- Keep smoking, drinking alcohol or consuming caffeinated foods or beverages (more than 8 cups, 1 cup = 250 mL) 2 days before taking the study drug and during the study; and those who have special dietary requirements and cannot follow the unified diet;
- Pregnant or lactating women;
- Drug screening or alcohol breath test is positive.
- Other conditions that the investigator believes the subject is not suitable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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
- Being tested
- HRS5091
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS5091Drug
Also called Placebo
Single dose in group 1-5
Multiple doses in group 6-9
| Study group | Role | What they receive |
|---|---|---|
| Part 1a Treatment group 1 | Experimental | Intervention: Drug1: HRS5091, dose 1; Drug2: Placebo Healthy subjects Receives: Drug: HRS5091 |
| Part 1a Treatment group 2 | Experimental | Intervention: Drug1: HRS5091, dose 2; Drug2: Placebo Healthy subjects Receives: Drug: HRS5091 |
| Part 1a Treatment group 3 | Experimental | Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects Receives: Drug: HRS5091 |
| Part 1a Treatment group 4 | Experimental | Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo Healthy subjects Receives: Drug: HRS5091 |
| Part 1a Treatment group 5 | Experimental | Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo Healthy subjects Receives: Drug: HRS5091 |
| Part 1b Treatment group 3 | Experimental | Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects Food effect Receives: Drug: HRS5091 |
| Part 1c Treatment group 6 | Experimental | Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects Receives: Drug: HRS5091 |
| Part 2 Treatment group 7 | Experimental | Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo CHB subjects Receives: Drug: HRS5091 |
| Part 2 Treatment group 8 | Experimental | Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo CHB subjects Receives: Drug: HRS5091 |
| Part 2 Treatment group 9 | Experimental | Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo CHB subjects Receives: Drug: HRS5091 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of treatment-related
adverse events as assessed by CTCAE v5.0
Measured: 29 DAYS for Group 1.2.4.5; 58 DAYS for Group 3; 42 DAYS for Group 6；56 DAYS for Group 7-9；
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Measured: 0-672 hours after each dose for Group 1-9
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Measured: 0-672 hours after each dose for Group 1-9
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Measured: 0-672 hours after each dose for Group 1-9
Apparent clearance [CL/F]
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Measured: 0-672 hours after each dose for Group 1-9
Half-time [t1/2]
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Measured: 0-672 hours after each dose for Group 1-9
Apparent volume of distribution [Vz/F(Vd)]
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Measured: 0-672 hours after each dose for Group 1-9
Mean retention time [MRT]
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Measured: 0-672 hours after each dose for Group 1-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start28 Jul 2020
- Primary completion23 Nov 2021 (estimated)
- Study completion23 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480294
- Sponsor's protocol ID
- HRS5091-101
- Status last verified
- Oct 2021
- First submitted
- 13 Jul 2020
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04480294
- Acronym / sponsor ID
- HRS5091-101
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 23 Nov 2021 (estimated)
- Study completion
- 23 Nov 2021 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part 1a Treatment group 1 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 1; Drug2: Placebo Healthy subjects |
| Part 1a Treatment group 2 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 2; Drug2: Placebo Healthy subjects |
| Part 1a Treatment group 3 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects |
| Part 1a Treatment group 4 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo Healthy subjects |
| Part 1a Treatment group 5 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo Healthy subjects |
| Part 1b Treatment group 3 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects Food effect |
| Part 1c Treatment group 6 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects |
| Part 2 Treatment group 7 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo CHB subjects |
| Part 2 Treatment group 8 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo CHB subjects |
| Part 2 Treatment group 9 | Experimental | Drug: HRS5091Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo CHB subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Healthy subjects
- CHB subjects
Key exclusion criteria (42 listed)
- Healthy subjects
- CHB subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS5091Also: PlaceboSingle dose in group 1-5 Multiple doses in group 6-9 | Drug | Part 1a Treatment group 1, Part 1a Treatment group 2, Part 1a Treatment group 3, Part 1a Treatment group 4, Part 1a Treatment group 5, Part 1b Treatment group 3, Part 1c Treatment group 6, Part 2 Treatment group 7, Part 2 Treatment group 8, Part 2 Treatment group 9 |
Primary outcome
The incidence and severity of treatment-related
Time frame: 29 DAYS for Group 1.2.4.5; 58 DAYS for Group 3; 42 DAYS for Group 6；56 DAYS for Group 7-9；
adverse events as assessed by CTCAE v5.0
Maximum Plasma Concentration [Cmax]
Time frame: 0-672 hours after each dose for Group 1-9
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Area under the concentration time curve [AUC]
Time frame: 0-672 hours after each dose for Group 1-9
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Time to maximum plasma concentration [Tmax]
Time frame: 0-672 hours after each dose for Group 1-9
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Apparent clearance [CL/F]
Time frame: 0-672 hours after each dose for Group 1-9
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Half-time [t1/2]
Time frame: 0-672 hours after each dose for Group 1-9
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Apparent volume of distribution [Vz/F(Vd)]
Time frame: 0-672 hours after each dose for Group 1-9
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Mean retention time [MRT]
Time frame: 0-672 hours after each dose for Group 1-9
Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS5091 in people with Chronic Hepatitis B, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of treatment-related (time frame: 29 DAYS for Group 1.2.4.5; 58 DAYS for Group 3; 42 DAYS for Group 6；56 DAYS for Group 7-9；). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.