AzTrials
AzTrials

Chronic Hepatitis bPhase 1NCT04464733

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

A Phase 1 study testing HRS9950 in people with Chronic Hepatitis b, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis b
What is being tested?
HRS9950
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
1 siteChina
Study dates
20 Jul 2020to 30 May 2023
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • 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.
Show all 21Show fewer
  • CHB subjects
  • Signed informed consent.
  • Aged 18~65.
  • CHB subjects should meet the following two criteria:
  • <!-- -->
  • IgM 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 4. Treatment-experienced CHB subjects should also meet the following criteria:
  • <!-- -->
  • Have received nucleoside analogue treatment for at least 6 months
  • HBeAg positive or negative, and the HBV DNA concentration should be less than 20 IU/mL for at least 6 months before enrollment
  • Confirm ALT <1.5 ULN (upper limit of normal value) by two measurements within 6 months before enrollment 5. Treatment-naïve CHB subjects should also meet the following criteria:
  • <!-- -->
  • Have not received antiviral therapy (nucleosides or interferons) at screening
  • HBeAg positive or negative, and the HBV DNA concentration should be greater than 2000 IU/mL for at least 6 months before enrollment
  • Confirm ALT> 1 ULN by two measurements within 6 months before enrollment 6. 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.
  • Medical history of malignant tumor.
  • Have a digestive system disease or a medical history of severe digestive system disease.
  • Have severe infection, severe trauma or major surgical operations within 3 months.
  • 12-ECG test have clinical significant abnormality or the QT interval (QTc) > 450 ms.
Show all 43Show fewer
  • Clinical laboratory examinations or chest radiographs have clinical significant abnormality.
  • Have a medical history of immune-mediated diseases.
  • Screening for infectious diseases is positive (Including HBsAg, Anti-HCV, TPPA, Anti-HIV).
  • 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 took any drugs within 5 half-lives at the time of screening; plan to take other drugs during the test period.
  • Participated in clinical trials of any drug or medical device within 3 months before screening, or within 5 half-lives before screening.
  • Had donated blood or blood transfusion in 8 weeks or ≥ 400 mL within 3 months prior to screening or ≥ 200 mL within 1 months.
  • 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.
  • Liver stiffness (LSM)> 12.4 kPa by noninvasive transient liver elastography (eg Fibroscan®) or recorded liver biopsy suggesting cirrhosis or extensive fibrosis
  • Primary liver cancer, high-risk groups of primary liver cancer or AFP> 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>1.5;
  • ALT exceeds 5 times the upper limit of normal value on screening/baseline visit
  • HIV and/or syphilis antibody positive
  • 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.
  • 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.

China1 site

  • Beijing Youan Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100069

Other trials in China

About this study

Official title: 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

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 .

Read more

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.

Being tested
HRS9950, Placebo
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.

  • HRS9950Drug

    HRS9950

  • PlaceboDrug

    Placebo

Study groups in NCT04464733
Study groupRoleWhat they receive
Treatment group AExperimentalsingle dose
Receives: Drug: HRS9950; Drug: Placebo
Treatment group BExperimentalsingle dose
Receives: Drug: HRS9950; Drug: Placebo
Treatment group CExperimentalsingle dose; food effect
Receives: Drug: HRS9950; Drug: Placebo
Treatment group DExperimentalsingle dose
Receives: Drug: HRS9950; Drug: Placebo
Treatment group EExperimentalsingle dose
Receives: Drug: HRS9950; Drug: Placebo
Treatment group FExperimentalmultiple doses
Receives: Drug: HRS9950; Drug: Placebo
Treatment group GExperimentalmultiple doses
Receives: Drug: HRS9950; Drug: Placebo
Treatment group HExperimentalmultiple doses
Receives: Drug: HRS9950; Drug: Placebo
Treatment group IExperimentalmultiple doses
Receives: Drug: HRS9950; Drug: Placebo
Treatment group JExperimentalmultiple doses
Receives: Drug: HRS9950; Drug: Placebo
Treatment group KExperimentalsingle dose
Receives: Drug: HRS9950; Drug: Placebo
Treatment group LExperimentalsingle dose
Receives: Drug: HRS9950; Drug: Placebo
Treatment group MExperimentalsingle dose
Receives: Drug: HRS9950; Drug: Placebo
Treatment group NExperimentalmultiple doses
Receives: Drug: HRS9950; Drug: Placebo
Treatment group OExperimentalmultiple doses
Receives: Drug: HRS9950; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Maximum Plasma Concentration [Cmax]

    Pharmacokinetic parameters of HRS9950, main metabolite and identified major metabolites in plasma

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

  3. Area under the concentration time curve [AUC]

    Pharmacokinetic parameters of HRS9950, main metabolite and identified major metabolites in plasma

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

  4. Time to maximum plasma concentration [Tmax]

    Pharmacokinetic parameters of HRS9950, main metabolite and identified major metabolites in plasma

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

  5. Apparent clearance [CL/F]

    Pharmacokinetic parameters of HRS9950, main metabolite and identified major metabolites in plasma

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

  6. Half-time [t1/2]

    Pharmacokinetic parameters of HRS9950, main metabolite and identified major metabolites in plasma

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

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

    Pharmacokinetic parameters of HRS9950, main metabolite and identified major metabolites in plasma

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

  8. Mean residence time [MRT]

    Pharmacokinetic parameters of HRS9950, main metabolite and identified major metabolites in plasma

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

  9. The concentration of IL-12p40 in the serum

    After single or multiple administration of HRS9950

    Measured: 0-48 hours after each dose for Group A-E、G-O

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start20 Jul 2020
  3. Primary completion30 May 2023
  4. Study completion30 May 2023

Resources

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
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464733
Sponsor's protocol ID
HRS9950-101
Status last verified
Nov 2024
First submitted
3 Jul 2020
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS9950 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 21 inclusion and 43 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: finished, as of the sponsor's last update on 5 Nov 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 adverse events as assessed by CTCAE v5.0 (time frame: 8 DAYS for Group A-M; 29 DAYS for Group F; 50 DAYS for Group G-O). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04464733.

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 5 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in