Clinical trials

2

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Condition / disease
Location
Status: Not yet recruiting

An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B

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.

Participants needed: 20
Trial details
Phase: Early Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Epigenic Therapeutics, IncUpdated: Dec 24, 2024Locations: 1
Eligibility criteria

Be between 18 and 65 years of age, inclusive, at the time of signing the informe... [+2]

Confirmed diagnosis of liver cancer or cirrhosis; [+1]

Status: Not yet recruiting

Study 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.

Participants needed: 36
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Epigenic Therapeutics, IncUpdated: Oct 28, 2024Locations: 4
Eligibility criteria

Aged 18 to 65 years (inclusive) at the time of signing the informed consent. [+7]

Evidence or history of liver disease of non-HBV aetiology. [+20]