Back to resultsEvaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Freethiadine tablets(part I)
Freethiadine tablets (part II)
Freethiadine placebo tablets
entecavir tablets
Sponsored by
About this trial
This is an interventional other trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- Southern Hospital of Southern Medical University
- The First Hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Active Comparator
Arm Label
Freethiadine tablets
Freethiadine placebo tablets
Freethiadine tablet
entecavir tablets
Arm Description
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
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
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
part 2(Patients with chronic hepatitis B): 0.5 mg
Outcomes
Primary Outcome Measures
Adverse Events
Incidence of adverse events
AUC
Maximum plasma concentration of study drugs
HBV DNA
Change from baseline in HBV DNA
Secondary Outcome Measures
HBsAg
Change from baseline in HBsAg
Full Information
NCT ID
NCT05391360
First Posted
May 20, 2022
Last Updated
April 11, 2023
Sponsor
Sunshine Lake Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05391360
Brief Title
Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
January 17, 2023 (Actual)
Study Completion Date
January 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Freethiadine tablets
Arm Type
Experimental
Arm Description
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
Arm Title
Freethiadine placebo tablets
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Freethiadine tablet
Arm Type
Experimental
Arm Description
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
Arm Title
entecavir tablets
Arm Type
Active Comparator
Arm Description
part 2(Patients with chronic hepatitis B): 0.5 mg
Intervention Type
Drug
Intervention Name(s)
Freethiadine tablets(part I)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Freethiadine tablets (part II)
Intervention Description
once or twice daily for consecutive 28 days
Intervention Type
Drug
Intervention Name(s)
Freethiadine placebo tablets
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
entecavir tablets
Intervention Description
once daily for consecutive 28 days
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of adverse events
Time Frame
From Days 1-35
Title
AUC
Description
Maximum plasma concentration of study drugs
Time Frame
Day 1-12
Title
HBV DNA
Description
Change from baseline in HBV DNA
Time Frame
Day 1-35
Secondary Outcome Measure Information:
Title
HBsAg
Description
Change from baseline in HBsAg
Time Frame
Day 1-35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JinLin Hou, Doctor
Organizational Affiliation
Southern Hospital of Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JunQI Niu, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanhua Ding, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
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