A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Study in Healthy Subjects and Chronic Hepatitis B Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Freethiadine

HEC160208-HBV-101

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

2021-10-11

2023-01-17

2023-01-17

Completed

Early phase I

128

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 128, 'type': 'ACTUAL'}}

2023-04-12