Hepatitis B, ChronicPhase 1/2NCT04536532
Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
A Phase 1/2 study testing HEC121120 tablets and entecavir tablets in people with Hepatitis B, Chronic, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug HEC121120 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?
- HEC121120 tablets 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
- 52 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 12 Mar 2023
- Phase
- Phase 1/2
- 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
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
- Be able to complete the study according to the trail protocol.
- Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
- 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.
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- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
- Be able to complete the study according to the trail protocol.
- Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
- subjects and must be 18 to 65 years of age inclusive.
- Body mass index（BMI）between 18 and 32 kg / m^2, inclusive.
- There is evidence of hepatitis B infection for more than 6 months。
- HBV DNA copies≥2.0×10^4 IU/mL.
- ALT≤5×ULN，TBIL≤2×ULN
- No cirrhosis.
Who cannot join
- Use of >5 cigarettes per day during the past 3 months.
- Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
- 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. 5.12-lead ECG with clinically significant.
- 6.Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis. 7.Subjects deemed unsuitable by the investigator for any other reason.
- Patients with chronic hepatitis B
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- Use of >5 cigarettes per day during the past 3 months.
- Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
- Female subjects were lactating or had positive serum pregnancy results during the screening or testing period.
- Donation or loss of blood over 450 mL within 3 months prior to screening. 5.12-lead ECG with clinically significant.
- 6.Positive for Viral hepatitis C, HIV and syphilis. 7. AFP>50 ng/mL. 8. eGFR<60 mL/min/1.73m^2 9.Subjects deemed unsuitable by the investigator for any other reason.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Jilin University
Jilin City, Changchun, 130000
About this study
Official title: A Single-center, Randomized, Double-blind, Single and Multiple Dosing, Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug HEC121120 in Healthy subjects and in patients with chronic hepatitis B
Read the detailed description
This study consists of two parts: healthy subjects and chronic hepatitis B patients. Healthy subjects will conduct a single-dose, multiple-dose and food effect study.
- Single-Dose Study：There will be a total of 6 dose cohorts（25 mg, 50 mg, 100 mg, 400 mg, 600 mg, 800 mg). 25 mg cohort as experimental cohort, plans to enroll 4 subjects (male or female) who will use HEC121120 tablets . The other else cohorts will include 10 subjects, of which 8 receives HEC121120 tablets and 2 receives placebo, regardless of gender. Each subject will only participate in one dose cohort. Each cohort will be divided into 2 group. The first group consists of 3 sentinels, two receiving active and one placebo. The second group will consist of the remainder of the cohort (6 active and 1 placebo) and, following review of the available safety data, will be dosed 24 hours after the sentinel group. Subjects can leave the pharmacy after their biological samples are collected on day 5. Subjects in each cohort will receive a single dose of HEC121120 or placebo in the fasted state on day 1, and safety evaluation is to be performed on day 2 and 5.
II. Food effect: There will be 1 dose cohort (200 mg), only to be admitted to the 100 mg dose cohort if a single dose has been completed and is safe and well tolerated. A total of 18 subjects were enrolled in this dose cohort, divided into two groups A and B (9 subjects in each group, 8 subjects in each group received HEC121120 and 1 received the placebo, with the ratio of male to female as close as possible. All subjects were required to participate in a single dose and food influence study on pharmacokinetics. Two cycles of cross-dose administration were performed, with a washout period of 7 days. Four sentinels were first enrolled in group A, and their safety indexes were evaluated by the investigator at least 24 h after administration. If tolerated, the remaining 5 sentinels could be enrolled in group A, and the remaining 4 sentinels could be enrolled in group B. The safety indexes were evaluated by the investigator at least 24 h after administration, if tolerated, the remaining 5 sentinels could be enrolled in group B.
III. Multi-Dose Study: There will be 1 dose(200 mg) cohort which will consist of 12 subjects, of which 10 receive HEC121120 tablets and 2 receive placebo, with the ratio of male to female as close as possible. All subjects will receive HEC121120 or placebo for 5 consecutive days (study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study). Subjects can leave pharmacy after their biological samples are collected. Safety evaluation is to be performed on day 3 and 7.
IV:Chronic hepatitis B patients: There will be a total of 3 dose cohorts (100、200、400 mg). Each cohort will consist of 14 subjects, of which 12 receive HEC121120 tablets and placebo(Entecavir simulation tablet), 2 receive Entecavir and placebo(HEC121120 simulation tablet). It is necessary to determine the administration method and dose for patients with chronic hepatitis B based on the results of the tolerance and PK study of healthy subjects. Each subject will only participate in one dose cohort.Initially, the drug frequency was set as once a day for 28 consecutive days. Safety and antiviral activity evaluation is to be performed on day 7, 14, 21±2, 29, 35±2.
- Conditions
- Hepatitis B, Chronic
- Being tested
- HEC121120 tablets, HEC121120 placebo tablets, entecavir tablets, entecavir placebo 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.
HEC121120 tabletsDrug
single-Dose Study: Each dose of HEC121120 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
multiple-dose study/Patients with chronic hepatitis B:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
HEC121120 placebo tabletsDrug
single-Dose Study: Each dose of HEC121120 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
multiple-dose study/Patients with chronic hepatitis B:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
entecavir tabletsDrug
Patients with chronic hepatitis B：Administered Entecavir orally once daily for consecutive 28 days in fasted state
entecavir placebo tabletsDrug
Patients with chronic hepatitis B：Administered Entecavir placebo orally once daily for consecutive 28 days in fasted state
| Study group | Role | What they receive |
|---|---|---|
| HEC121120 tablets | Experimental | part 1(Health volunteer): single-Dose Study: There will be a total of 6 dose cohorts: 25 mg、50 mg、100 mg、400 mg、600 mg、800 mg food effect：200 mg multiple-dose study: 200 mg part 2(Patients with chronic hepatitis B): There will be a total of 3 dose cohorts:100、200、400 mg Receives: Drug: HEC121120 tablets |
| HEC121120 placebo tablets | Placebo comparator | part 1(Health volunteer): single-Dose Study: There will be a total of 6 dose cohorts: 25 mg、50 mg、100 mg、400 mg、600 mg、800 mg food effect：200 mg multiple-dose study: 200 mg part 2(Patients with chronic hepatitis B): There will be a total of 3 dose cohorts:100、200、400 mg Receives: Drug: HEC121120 placebo tablets |
| entecavir tablets | Active comparator | part 2(Patients with chronic hepatitis B): 0.5 mg Receives: Drug: entecavir tablets |
| entecavir placebo tablets | Placebo comparator | part 2(Patients with chronic hepatitis B): 0.5 mg Receives: Drug: entecavir placebo 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: Time Frame: From Days 1-35
Cmax
Maximum plasma concentration of study drugs
Measured: Time Frame: Day 1-7
AUC
Maximum plasma concentration of study drugs
Measured: Time Frame: Day 1-7
HBV DNA
Hepatitis B virus DNA
Measured: Time Frame: Day 29-35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start9 Oct 2020
- Primary completion12 Mar 2023
- Study completion12 Mar 2023
Why it stopped: Company decision to discontinue trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536532
- Sponsor's protocol ID
- HEC121120-P-01
- Status last verified
- Jun 2024
- First submitted
- 28 Aug 2020
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Single and Multiple Dosing, Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
- ClinicalTrials.gov ID
- NCT04536532
- Acronym / sponsor ID
- HEC121120-P-01
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision to discontinue trial
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 2 Sep 2020 (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 HEC121120 in Healthy subjects and in patients with chronic hepatitis B
Detailed description
This study consists of two parts: healthy subjects and chronic hepatitis B patients. Healthy subjects will conduct a single-dose, multiple-dose and food effect study.
- Single-Dose Study：There will be a total of 6 dose cohorts（25 mg, 50 mg, 100 mg, 400 mg, 600 mg, 800 mg). 25 mg cohort as experimental cohort, plans to enroll 4 subjects (male or female) who will use HEC121120 tablets . The other else cohorts will include 10 subjects, of which 8 receives HEC121120 tablets and 2 receives placebo, regardless of gender. Each subject will only participate in one dose cohort. Each cohort will be divided into 2 group. The first group consists of 3 sentinels, two receiving active and one placebo. The second group will consist of the remainder of the cohort (6 active and 1 placebo) and, following review of the available safety data, will be dosed 24 hours after the sentinel group. Subjects can leave the pharmacy after their biological samples are collected on day 5. Subjects in each cohort will receive a single dose of HEC121120 or placebo in the fasted state on day 1, and safety evaluation is to be performed on day 2 and 5.
II. Food effect: There will be 1 dose cohort (200 mg), only to be admitted to the 100 mg dose cohort if a single dose has been completed and is safe and well tolerated. A total of 18 subjects were enrolled in this dose cohort, divided into two groups A and B (9 subjects in each group, 8 subjects in each group received HEC121120 and 1 received the placebo, with the ratio of male to female as close as possible. All subjects were required to participate in a single dose and food influence study on pharmacokinetics. Two cycles of cross-dose administration were performed, with a washout period of 7 days. Four sentinels were first enrolled in group A, and their safety indexes were evaluated by the investigator at least 24 h after administration. If tolerated, the remaining 5 sentinels could be enrolled in group A, and the remaining 4 sentinels could be enrolled in group B. The safety indexes were evaluated by the investigator at least 24 h after administration, if tolerated, the remaining 5 sentinels could be enrolled in group B.
III. Multi-Dose Study: There will be 1 dose(200 mg) cohort which will consist of 12 subjects, of which 10 receive HEC121120 tablets and 2 receive placebo, with the ratio of male to female as close as possible. All subjects will receive HEC121120 or placebo for 5 consecutive days (study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study). Subjects can leave pharmacy after their biological samples are collected. Safety evaluation is to be performed on day 3 and 7.
IV:Chronic hepatitis B patients: There will be a total of 3 dose cohorts (100、200、400 mg). Each cohort will consist of 14 subjects, of which 12 receive HEC121120 tablets and placebo(Entecavir simulation tablet), 2 receive Entecavir and placebo(HEC121120 simulation tablet). It is necessary to determine the administration method and dose for patients with chronic hepatitis B based on the results of the tolerance and PK study of healthy subjects. Each subject will only participate in one dose cohort.Initially, the drug frequency was set as once a day for 28 consecutive days. Safety and antiviral activity evaluation is to be performed on day 7, 14, 21±2, 29, 35±2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HEC121120 tablets | Experimental | Drug: HEC121120 tabletspart 1(Health volunteer): single-Dose Study: There will be a total of 6 dose cohorts: 25 mg、50 mg、100 mg、400 mg、600 mg、800 mg food effect：200 mg multiple-dose study: 200 mg part 2(Patients with chronic hepatitis B): There will be a total of 3 dose cohorts:100、200、400 mg |
| HEC121120 placebo tablets | Placebo comparator | Drug: HEC121120 placebo tabletspart 1(Health volunteer): single-Dose Study: There will be a total of 6 dose cohorts: 25 mg、50 mg、100 mg、400 mg、600 mg、800 mg food effect：200 mg multiple-dose study: 200 mg part 2(Patients with chronic hepatitis B): There will be a total of 3 dose cohorts:100、200、400 mg |
| entecavir tablets | Active comparator | Drug: entecavir tabletspart 2(Patients with chronic hepatitis B): 0.5 mg |
| entecavir placebo tablets | Placebo comparator | Drug: entecavir placebo 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 (15 listed)
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
- Be able to complete the study according to the trail protocol.
- Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
- 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.
Key exclusion criteria (11 listed)
- Use of >5 cigarettes per day during the past 3 months.
- Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
- 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. 5.12-lead ECG with clinically significant.
- 6.Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis. 7.Subjects deemed unsuitable by the investigator for any other reason.
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 |
|---|---|---|
| HEC121120 tabletssingle-Dose Study: Each dose of HEC121120 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. multiple-dose study/Patients with chronic hepatitis B:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study. | Drug | HEC121120 tablets |
| HEC121120 placebo tabletssingle-Dose Study: Each dose of HEC121120 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. multiple-dose study/Patients with chronic hepatitis B:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study. | Drug | HEC121120 placebo tablets |
| entecavir tabletsPatients with chronic hepatitis B：Administered Entecavir orally once daily for consecutive 28 days in fasted state | Drug | entecavir tablets |
| entecavir placebo tabletsPatients with chronic hepatitis B：Administered Entecavir placebo orally once daily for consecutive 28 days in fasted state | Drug | entecavir placebo tablets |
Primary outcome
Adverse Events
Time frame: Time Frame: From Days 1-35
Incidence of adverse events
Cmax
Time frame: Time Frame: Day 1-7
Maximum plasma concentration of study drugs
AUC
Time frame: Time Frame: Day 1-7
Maximum plasma concentration of study drugs
HBV DNA
Time frame: Time Frame: Day 29-35
Hepatitis B virus DNA
Results and safety
The study was stopped early (reason given: Company decision to discontinue trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HEC121120 tablets and entecavir tablets in people with Hepatitis B, Chronic, run by Sunshine Lake Pharma Co., Ltd. at 1 site 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 15 inclusion and 11 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: stopped early, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Company decision to discontinue trial). Results are not available in the source record.
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: Time Frame: From Days 1-35). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2024.