Hepatitis B
Conditions
Interventions
Group 1:Ten subjects were enrolled,8 received the trial drug and 2 received placebo, and the male-to-female ratio was close to 1:1. 0.5 mg was administered at D1, D3, D5, D7, D9, and safety was checke
Group 2:Ten subjects were enrolled,8 received the trial drug and 2 received placebo, and the male-to-female ratio was close to 1:1. 1.0 mg was administered at D1, D3, D5, D7, D9, and safety was checke
Group 3:Ten subjects were enrolled,8 received the trial drug and 2 received placebo, and the male-to-female ratio was close to 1:1. 0.5 mg each time for 10 consecutive days, and safety tests were perf
Group 4:Ten subjects were enrolled,8 received the trial drug and 2 received placebo, and the male-to-female ratio was close to 1:1. 2.0 mg was administered on D1, D4, D7, D10
The safety of D5, D10 and D14 was checked, and the tolerability evaluation was performed on D5, D14.
Group 5:Ten subjects were enrolled,8 received the trial drug and 2 received placebo, and the male-to-female ratio was close to 1:1. 2.0 mg was administered on D1, D3, D5, D7, D9, and safety was checke
Group 6:Ten subjects were enrolled,8 received the trial drug and 2 received placebo, and the male-to-female ratio was close to 1:1. 0.2 mg each time for 10 consecutive days, and safety tests were perf
Group 7:Ten subjects were enrolled,8 received the trial drug and 2 received placebo, and the male-to-female ratio was close to 1:1. 1.5 mg was administered on D1, D4, D7, D10
The safe
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Sign an informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test; 2) Be able to complete the research according to the requirements of the plan; 3) Male and female subjects aged 18 to 55 years (including critical value); 4) Male subjects weigh not less than 50 kg, female subjects weigh not less than 45 kg, Body Mass Index (BMI) in the range of 18 ~ 28 kg / m2 (including critical value); 5) No clinically significant medical history of cardiac, hepatic, renal, gastrointestinal, neurological, respiratory, psychiatric abnormalities and metabolic abnormalities; 6) Subjects (including partners) are willing to voluntarily take effective contraception within 6 months from screening to the last study drug administration.
Exclusion criteria
Exclusion criteria: Female subjects who are breastfeeding or have recently become pregnant or have a positive seropregnancy result during the Screening Period or during the course of the test; 2) A pre-existing or current neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic-lymphatic, hepatic or renal insufficiency, endocrine, or musculoskeletal disease or other condition which, in the judgment of the Investigator, may have an effect on drug metabolism or safety; 3) Eye diseases, including fundus lesions; 4) History of clinically significant infections, including upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), requiring antibiotic or antiviral medication 14 days prior to and during screening; 5) Acute illness or concomitant medication from the screening phase until study drug administration; 6) History of dysphagia or any gastrointestinal disorder that interferes with drug absorption; 7) Abnormal and clinically significant findings on vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, abdominal ultrasound, and chest radiographs during the screening period; 8) Positive for HBsAg in Hepatitis B, Hepatitis C, Syphilis, and Human Immunodeficiency Virus (HIV) antigen/antibody; 9) Within 28 days prior to screening, any medication that can alter liver drug enzyme activity was taken; 10) Received immunoglobulin or blood product therapy within 30 days prior to screening; 11) Have taken an investigational drug or participated in a clinical trial of any drug within 3 months prior to screening; 12) Any prescription, over-the-counter, vitamin product, or herbal medication taken within 2 weeks prior to screening; 13) Use of any systemic cytotoxic or systemic immunosuppressive drug within 6 months prior to screening or during the study period, or use of any localized cytotoxic or localized immunosuppressive drug within 30 days or 5 half-lives, whichever is longer, prior to screening or during the study period; 14) Who have undergone surgery within 4 weeks prior to screening or who plan to undergo surgery during the study period; 15) Those who have lost blood or donated more than 400 mL of blood within 2 months prior to screening; 16) Potential blood collection difficulties, history of needle and blood sickness; 17) Having any clear history of drug or food allergy, especially to ingredients similar to those of the test drug; 18) Those who smoked more than 5 cigarettes/day or used an equivalent amount of nicotine or nicotine-containing products in the 3 months prior to screening, or who were unable to discontinue the use of any tobacco-based products during the trial; 19) Persons who have a history of chronic alcohol abuse or who have consumed more than 14 units of alcohol per week in the 3 months prior to screening or who are unable to abstain from alcohol for the duration of the test or who have a positive breathalyzer test for alcohol; 20) Those with a history of substance abuse or a positive urine drug screen; 21) Avoid xanthine-rich beverages or foods for at least 1 day prior to dosing until the end of the study, or there may be other actors that may affect drug absorption, distribution, metabolism, excretion, etc; 22) Subjects who, in the opinion of the investigator, have other factors that make them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events and serious adverse events;Abnormal Clinical Laboratory Test Indicators; vital signs;clinical examination;12-lead electrocardiogram; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood concentration;IFN-a;ISG;TNF-a;IL-6;MCP-1;IP-10; Level of change in the QT/QTc interval;IFN-?;IL-2; | — |
Countries
China
Contacts
Public ContactHong Zhang
The first hospital of Jilin University
Outcome results
None listed