Hepatitis B, Chronic
Conditions
Brief summary
The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B
Interventions
DRUGFreethiadine tablets(part I)
Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV)
DRUGFreethiadine tablets (part II)
once or twice daily for consecutive 28 days
DRUGFreethiadine placebo tablets
Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV)
once daily for consecutive 28 days
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Health volunteer: 1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. 2. subjects and must be 18 to 45 years of age inclusive. 3. Body weight ≥ 45 kg and body mass index（BMI）between 18 and 28 kg / m\^2, inclusive. 4. Physical examination and vital signs without clinically significant abnormalities. Patients with chronic hepatitis B: 1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. 2. subjects and must be 18 to 65 years of age inclusive. 3. Body mass index（BMI）between 18 and 32 kg / m\^2, inclusive. 4. No cirrhosis.
Exclusion criteria
Health volunteer: 1. Use of \>5 cigarettes per day during the past 3 months. 2. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine). 3. Donation or loss of blood over 450 mL within 3 months prior to screening. Patients with chronic hepatitis B: 1. AFP\>50 ng/mL. 2. INR\>1.5. 3. Positive for Viral hepatitis C, HIV and syphilis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From Days 1-35 | Incidence of adverse events |
| AUC | Day 1-12 | Maximum plasma concentration of study drugs |
| HBV DNA | Day 1-35 | Change from baseline in HBV DNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBsAg | Day 1-35 | Change from baseline in HBsAg |
Countries
China
Outcome results
None listed