Status:
COMPLETED
Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- Health volunteer:
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
- subjects and must be 18 to 45 years of age inclusive.
- Body weight ≥ 45 kg and body mass index（BMI）between 18 and 28 kg / m\^2, inclusive.
- Physical examination and vital signs without clinically significant abnormalities.
- Patients with chronic hepatitis B:
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
- subjects and must be 18 to 65 years of age inclusive.
- Body mass index（BMI）between 18 and 32 kg / m\^2, inclusive.
- No cirrhosis.
Exclusion
- Health volunteer:
- Use of \>5 cigarettes per day during the past 3 months.
- 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).
- Donation or loss of blood over 450 mL within 3 months prior to screening.
- Patients with chronic hepatitis B:
- AFP\>50 ng/mL.
- INR\>1.5.
- Positive for Viral hepatitis C, HIV and syphilis.
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2023
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05391360
Start Date
October 11 2021
End Date
January 17 2023
Last Update
April 12 2023
Active Locations (2)
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1
Southern Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
2
The First Hospital of Jilin University
Changchun, Jilin, China, 130000