Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
NCT ID: NCT05391360
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
128 participants
INTERVENTIONAL
2021-10-11
2023-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Freethiadine tablets
part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg
Freethiadine 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)
Freethiadine placebo tablets
part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg
Freethiadine 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)
Freethiadine tablet
part 2(Patients with chronic hepatitis B): There will be a total of 4 dose cohorts:100 mg、200 mg(BID or QD)、300 mg
Freethiadine tablets (part II)
once or twice daily for consecutive 28 days
entecavir tablets
part 2(Patients with chronic hepatitis B): 0.5 mg
entecavir tablets
once daily for consecutive 28 days
Interventions
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Freethiadine 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)
Freethiadine tablets (part II)
once or twice daily for consecutive 28 days
Freethiadine 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)
entecavir tablets
once daily for consecutive 28 days
Eligibility Criteria
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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. 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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Sunshine Lake Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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JinLin Hou, Doctor
Role: PRINCIPAL_INVESTIGATOR
Southern Hospital of Southern Medical University
JunQI Niu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Yanhua Ding, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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Southern Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Other Identifiers
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HEC160208-HBV-101
Identifier Type: -
Identifier Source: org_study_id
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