Chronic Hepatitis BPhase 1NCT06661148
Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients
A Phase 1 study testing EPI-003 in people with Chronic Hepatitis B and HBV (Hepatitis B Virus), run by Epigenic Therapeutics, Inc at 4 sites in 3 countries.
Trial summary
This study is an open-label, 2-Part (Single Ascending Dose [Part 1] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B, HBV (Hepatitis B Virus)
- What is being tested?
- EPI-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Dec 2024to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years (inclusive) at the time of signing the informed consent.
- Body mass index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2 at Screening, and body weight of ≤ 120 kg.
- Chronic HBV infection for ≥ 6 months prior to Screening (eg, positive for serum HBsAg, HBV DNA, HBeAg for ≥ 6 months ) or serum immunoglobulin M (IgM) anti-HBc (hepatitis B core antibody) negative at Screening; AND Baseline HBsAg positive at Screening.
- Has received treatment with a NA (entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide) as a stable dose for ≥ 6 months before Screening and plans to continue at the same dose level for the duration of the study. Participants may be on other NAs but require Sponsor approval before enrolment.
- HBV DNA < LLOQ (according to local guidelines) for ≥ 6 months and at Screening
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN) at Screening.
- Able and willing to attend the necessary visits to the study site.
- Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Who cannot join
- Evidence or history of liver disease of non-HBV aetiology.
- Previous history or current diagnosis of significant liver fibrosis or cirrhosis
- Liver ultrasound or other imaging with findings suggestive of HCC at any time.
- Participants with serum alpha-fetoprotein (AFP) ≥ 200 ng/mL at Screening.
- Positive test result for HIV-1 or HIV-2 that suggests a concurrent infection at Screening.
- History of acute febrile illness, symptomatic viral, bacterial, or fungal infection within 1 week before Day 1.
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- History of receiving HBV vaccine or other HBV-targeted therapeutic within the 6 months before Day 1.
- Previous treatment with an HBV-targeted treatment other than NAs within the 6 months before Day 1 or planned use during the study.
- Any of the laboratory values at Screening (Screening laboratory tests may be repeated once for values thought to be erroneous OR not clinically significant as per the PI):
- Immunodeficient or autoimmune conditions due to disease.
- Chronic treatment with immunosuppressants.
- Any history of unexplained blackouts, fainting episodes, significant arrythmias, clinically significant abnormality of ECG, marked QT abnormalities, or any known risk factors for Torsade de Points
- History of anaphylaxis, hypersensitivity, or significant drug allergies.
- Received any antiplatelet or antithrombotic therapy.
- History of thrombophilia or history of a positive genetic test for Factor V Leiden and/or prothrombin 20210.
- Known or suspected intolerance or hypersensitivity to the IP components.
- Have received any other IP within 30 days or 5 half-lives of Day 1.
- Have received any vaccination within 14 days prior to Day 1 or vaccination planned for 3 months following administration of IP.
- Received any medications or other treatments that may adversely affect the immune system.
- Excess alcohol consumption within 3 months of Screening.
- Significant drug abuse/addiction within 3 months of Screening.
- Any safety concern or personal condition that is inappropriate for study participation per the Investigator's judgement.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
New Zealand2 sites
Epigenic Therapeutics Investigational Site
Christchurch
Epigenic Therapeutics Investigational Site
Grafton, Auckland
Australia1 site
Epigenic Therapeutics Investigational Site
Westmead, New South Wales
About this study
Official title: A Phase 1, Open-Label, 2-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients.
This study is an open-label, 2-Part (Single Ascending Dose [Part 1] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself. This study is designed to determine the safety and pharmacokinetic (PK) and pharmacodynamic (PD) profile of EPI-003 in this patient population.
- Conditions
- Chronic Hepatitis B, HBV (Hepatitis B Virus)
- Being tested
- EPI-003
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-003Drug
Intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| EPI-003 group | Experimental | Part A：Single Ascending Dose； Part B：Dose Expansion Receives: Drug: EPI-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Measured: From Baseline through to Day 28 postdose
Secondary outcomes (4)
Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg
Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg
Measured: From Baseline (predose on Day 1) at Day 3, Day 7, Day 14, Day 28, Day 56, Day 84, Day 112, and Day 182, and Day 365 postdose for the following parameters
Evaluation of maximum observed concentration (Cmax)
Evaluation of maximum observed concentration (Cmax)
Measured: Day 1, Day 3, Day 14, and Day 28
Evaluation of maximum observed concentration (tmax)
Evaluation of maximum observed concentration (tmax)
Measured: Day 1, Day 3, Day 14, and Day 28
Evaluation of terminal elimination half-life (t1/2)
Evaluation of terminal elimination half-life (t1/2)
Measured: Day 1, Day 3, Day 14, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epigenic Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661148
- Sponsor's protocol ID
- EPI-003-001
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 2-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients.
- ClinicalTrials.gov ID
- NCT06661148
- Acronym / sponsor ID
- EPI-003-001
- Conditions
- Chronic Hepatitis B, HBV (Hepatitis B Virus)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Epigenic Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Oct 2024 (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.
This study is an open-label, 2-Part (Single Ascending Dose [Part 1] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself. This study is designed to determine the safety and pharmacokinetic (PK) and pharmacodynamic (PD) profile of EPI-003 in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPI-003 group | Experimental | Drug: EPI-003Part A：Single Ascending Dose； Part B：Dose Expansion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 65 years (inclusive) at the time of signing the informed consent.
- Body mass index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2 at Screening, and body weight of ≤ 120 kg.
- Chronic HBV infection for ≥ 6 months prior to Screening (eg, positive for serum HBsAg, HBV DNA, HBeAg for ≥ 6 months ) or serum immunoglobulin M (IgM) anti-HBc (hepatitis B core antibody) negative at Screening; AND Baseline HBsAg positive at Screening.
- Has received treatment with a NA (entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide) as a stable dose for ≥ 6 months before Screening and plans to continue at the same dose level for the duration of the study. Participants may be on other NAs but require Sponsor approval before enrolment.
- HBV DNA < LLOQ (according to local guidelines) for ≥ 6 months and at Screening
Key exclusion criteria (22 listed)
- Evidence or history of liver disease of non-HBV aetiology.
- Previous history or current diagnosis of significant liver fibrosis or cirrhosis
- Liver ultrasound or other imaging with findings suggestive of HCC at any time.
- Participants with serum alpha-fetoprotein (AFP) ≥ 200 ng/mL at Screening.
- Positive test result for HIV-1 or HIV-2 that suggests a concurrent infection at Screening.
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 |
|---|---|---|
| EPI-003Intravenous (IV) infusion. | Drug | EPI-003 group |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: From Baseline through to Day 28 postdose
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
4 secondary outcomes
Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg
Time frame: From Baseline (predose on Day 1) at Day 3, Day 7, Day 14, Day 28, Day 56, Day 84, Day 112, and Day 182, and Day 365 postdose for the following parameters
Evaluation of maximum observed concentration (Cmax)
Time frame: Day 1, Day 3, Day 14, and Day 28
Evaluation of maximum observed concentration (tmax)
Time frame: Day 1, Day 3, Day 14, and Day 28
Evaluation of terminal elimination half-life (t1/2)
Time frame: Day 1, Day 3, Day 14, and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPI-003 in people with Chronic Hepatitis B and HBV (Hepatitis B Virus), run by Epigenic Therapeutics, Inc at 4 sites in 3 countries.
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 8 inclusion and 22 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: opening soon, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in New Zealand, Australia, 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Epigenic Therapeutics Clinical Trials (86-17621694653, xinyu.feng@epigenictx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). (time frame: From Baseline through to Day 28 postdose). 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 28 Oct 2024.