chronic hepatitis B
Conditions
Interventions
Experimental group:Freezer fixed film
Control group:placebo
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2.Be able to complete the study according to the trail protocol; 3.Subjects (and their partners) are willing to use effective contraception voluntarily from signing the informed consent until 3 months after the end of the last experimental drug; 4.Subjects should weigh at least 50 kg, have a BMI of weight (kg)/height ^2 (m^2), and a BMI of 18-28 kg/m^2 (including thresholds).
Exclusion criteria
Exclusion criteria: 1.In the 3 months before the experiment, the average daily smoking was more than 5 cigarettes; 2.Allergies constitution ( multiple drug and food allergies); 3.History of alcohol abuse (alcoholism is defined as: 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine); 4.Donation or loss of blood over 450 mL within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;The logarithm of hepatitis B virus, deoxyribonucleic acid copy number (base 10) at each test time point decreased by mean from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;The logarithm (base 10) of HBsAg at different test time points in each group decreased to mean from baseline;Logarithms of HBeAg at different test time points in each group (base 10) mean reduction from baseline (for HBeAg-positive subjects); | — |
Countries
China
Contacts
Public ContactChen Yujie
Guangdong East Sunshine Pharmaceutical Co. LTD
Outcome results
None listed