Hepatitis B, ChronicPhase 1NCT05391360
Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
A Phase 1 study testing Freethiadine tablets(part I), Freethiadine tablets (part II) and entecavir tablets in people with Hepatitis B, Chronic, run by Sunshine Lake Pharma Co., Ltd. at 2 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Freethiadine tablets(part I), Freethiadine tablets (part II) and entecavir tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesChina
- Study dates
- 11 Oct 2021to 17 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Hospital of Jilin University
Changchun, Jilin, 130000
Southern Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
About this 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
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
- Conditions
- Hepatitis B, Chronic
- Being tested
- Freethiadine tablets(part I), Freethiadine tablets (part II), Freethiadine placebo tablets, entecavir tablets
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freethiadine tablets(part I)Drug
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)Drug
once or twice daily for consecutive 28 days
Freethiadine placebo tabletsDrug
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 tabletsDrug
once daily for consecutive 28 days
| Study group | Role | What they receive |
|---|---|---|
| Freethiadine tablets | Experimental | 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 Receives: Drug: Freethiadine tablets(part I) |
| Freethiadine placebo tablets | Placebo comparator | 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 Receives: Drug: Freethiadine placebo tablets |
| Freethiadine tablet | Experimental | 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 Receives: Drug: Freethiadine tablets (part II) |
| entecavir tablets | Active comparator | part 2(Patients with chronic hepatitis B): 0.5 mg Receives: Drug: entecavir tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence of adverse events
Measured: From Days 1-35
AUC
Maximum plasma concentration of study drugs
Measured: Day 1-12
HBV DNA
Change from baseline in HBV DNA
Measured: Day 1-35
Secondary outcomes (1)
HBsAg
Change from baseline in HBsAg
Measured: Day 1-35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start11 Oct 2021
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JinLin Hou, Doctor, Principal investigator, Southern Hospital of Southern Medical UniversityJunQI Niu, Doctor, Principal investigator, The First Hospital of Jilin UniversityYanhua Ding, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391360
- Sponsor's protocol ID
- HEC160208-HBV-101
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li X, Xu J, Sun J, Liu J, Wu M, Zhang H, Zhu X, Li C, Zhang Y, Zhu J, Chen Y, Luo L, He Q, Zhuang Y, Chen Y, Niu J, Ding Y. Safety, Pharmacokinetics and Antiviral Efficacy of Capsid Assembly Modulator Freethiadine in Healthy Volunteers and Chronic Hepatitis B Patients. Liver Int. 2025 Jan;45(1):e16213. doi: 10.1111/liv.16213.
PubMed 39673713
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05391360
- Acronym / sponsor ID
- HEC160208-HBV-101
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Freethiadine tablets | Experimental | Drug: Freethiadine tablets(part I)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 | Placebo comparator | Drug: Freethiadine placebo tabletspart 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 tablet | Experimental | Drug: Freethiadine tablets (part II)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 |
| entecavir tablets | Active comparator | Drug: entecavir tabletspart 2(Patients with chronic hepatitis B): 0.5 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
Key exclusion criteria (8 listed)
- 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.
- AFP>50 ng/mL.
- INR>1.5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Freethiadine tablets |
| Freethiadine tablets (part II)once or twice daily for consecutive 28 days | Drug | Freethiadine tablet |
| Freethiadine placebo tabletsSubjects 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) | Drug | Freethiadine placebo tablets |
| entecavir tabletsonce daily for consecutive 28 days | Drug | entecavir tablets |
Primary outcome
Adverse Events
Time frame: From Days 1-35
Incidence of adverse events
AUC
Time frame: Day 1-12
Maximum plasma concentration of study drugs
HBV DNA
Time frame: Day 1-35
Change from baseline in HBV DNA
1 secondary outcome
HBsAg
Time frame: Day 1-35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 39673713Li X, Xu J, Sun J, Liu J, Wu M, Zhang H, Zhu X, Li C, Zhang Y, Zhu J, Chen Y, Luo L, He Q, Zhuang Y, Chen Y, Niu J, Ding Y. Safety, Pharmacokinetics and Antiviral Efficacy of Capsid Assembly Modulator Freethiadine in Healthy Volunteers and Chronic Hepatitis B Patients. Liver Int. 2025 Jan;45(1):e16213. doi: 10.1111/liv.16213.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JinLin Hou, Doctor principal investigator
Southern Hospital of Southern Medical University
JunQI Niu, Doctor principal investigator
The First Hospital of Jilin University
Yanhua Ding, Doctor principal investigator
The First Hospital of Jilin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Freethiadine tablets(part I), Freethiadine tablets (part II) and entecavir tablets in people with Hepatitis B, Chronic, run by Sunshine Lake Pharma Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From Days 1-35). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05391360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.