Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEpigenic Therapeutics, Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
EPI-003
DrugIntravenous (IV) infusion.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: EPI-003 groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame
From Baseline through to Day 28 postdoseSecondary outcomes
1
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
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 parameters2
Evaluation of maximum observed concentration (Cmax)
Evaluation of maximum observed concentration (Cmax)
Time frame
Day 1, Day 3, Day 14, and Day 283
Evaluation of maximum observed concentration (tmax)
Evaluation of maximum observed concentration (tmax)
Time frame
Day 1, Day 3, Day 14, and Day 284
Evaluation of terminal elimination half-life (t1/2)
Evaluation of terminal elimination half-life (t1/2)
Time frame
Day 1, Day 3, Day 14, and Day 28Other outcomes
1
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame
Up to day365Sponsors and contacts
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Source ClinicalTrials.gov
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