Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics(PK), Pharmacodynamics(PD) and Food Effect of HRS9950 in Healthy and CHB Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-65 years
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 HRS9950. 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 the following two criteria:
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- 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:
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- 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:
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- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04464733
Start Date
July 20 2020
End Date
May 30 2023
Last Update
November 5 2024
Active Locations (1)
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1
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100069