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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06661148




Registration number
NCT06661148
Ethics application status
Date submitted
21/10/2024
Date registered
28/10/2024
Date last updated
28/10/2024

Titles & IDs
Public title
Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients
Scientific 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.
Secondary ID [1] 0 0
EPI-003-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
HBV (Hepatitis B Virus) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EPI-003

Experimental: EPI-003 group - Part A:Single Ascending Dose; Part B:Dose Expansion


Treatment: Drugs: EPI-003
Intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Timepoint [1] 0 0
From Baseline through to Day 28 postdose
Secondary outcome [1] 0 0
Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Evaluation of maximum observed concentration (Cmax)
Timepoint [2] 0 0
Day 1, Day 3, Day 14, and Day 28
Secondary outcome [3] 0 0
Evaluation of maximum observed concentration (tmax)
Timepoint [3] 0 0
Day 1, Day 3, Day 14, and Day 28
Secondary outcome [4] 0 0
Evaluation of terminal elimination half-life (t1/2)
Timepoint [4] 0 0
Day 1, Day 3, Day 14, and Day 28

Eligibility
Key inclusion criteria
1. Aged 18 to 65 years (inclusive) at the time of signing the informed consent.
2. Body mass index (BMI) = 18 kg/m2 and = 35 kg/m2 at Screening, and body weight of = 120 kg.
3. 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.
4. 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.
5. HBV DNA < LLOQ (according to local guidelines) for = 6 months and at Screening
6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2 × upper limit of normal (ULN) at Screening.
7. Able and willing to attend the necessary visits to the study site.
8. 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence or history of liver disease of non-HBV aetiology.
2. Previous history or current diagnosis of significant liver fibrosis or cirrhosis
3. Liver ultrasound or other imaging with findings suggestive of HCC at any time.
4. Participants with serum alpha-fetoprotein (AFP) = 200 ng/mL at Screening.
5. Positive test result for HIV-1 or HIV-2 that suggests a concurrent infection at Screening.
6. History of acute febrile illness, symptomatic viral, bacterial, or fungal infection within 1 week before Day 1.
7. History of receiving HBV vaccine or other HBV-targeted therapeutic within the 6 months before Day 1.
8. Previous treatment with an HBV-targeted treatment other than NAs within the 6 months before Day 1 or planned use during the study.
9. 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):
10. Immunodeficient or autoimmune conditions due to disease.
11. Chronic treatment with immunosuppressants.
12. 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
13. History of anaphylaxis, hypersensitivity, or significant drug allergies.
14. Received any antiplatelet or antithrombotic therapy.
15. History of thrombophilia or history of a positive genetic test for Factor V Leiden and/or prothrombin 20210.
16. Known or suspected intolerance or hypersensitivity to the IP components.
17. Have received any other IP within 30 days or 5 half-lives of Day 1.
18. Have received any vaccination within 14 days prior to Day 1 or vaccination planned for 3 months following administration of IP.
19. Received any medications or other treatments that may adversely affect the immune system.
20. Excess alcohol consumption within 3 months of Screening.
21. Significant drug abuse/addiction within 3 months of Screening.
22. Any safety concern or personal condition that is inappropriate for study participation per the Investigator's judgement.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Epigenic Therapeutics Investigational Site - Westmead
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hong Kong
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Epigenic Therapeutics, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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). 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.
Trial website
https://clinicaltrials.gov/study/NCT06661148
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Epigenic Therapeutics Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
86-17621694653
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06661148