Status:
UNKNOWN
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
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04480294
Start Date
July 28 2020
End Date
November 23 2021
Last Update
October 22 2021
Active Locations (1)
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1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433