Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects

Hepatitis B, Chronic Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the FXR-agonist EYP001a in Chronically HBV Infected Subjects

Status Completed

Clinical Trial Summary

Bile acids regulating farnesoid X receptor (FXR) interact with hepatitis B virus replication. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B.

This Phase 1b study is designed primarily to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of EYP001a in chronically HBV infected subjects.

Clinical Trial Description

This is a multicenter, randomized, double-blind, placebo-controlled two-part trial.

In Part A, EYP001a will be administered as 29 days monotherapy. Three dose-levels and 2 dosing regimens of EYP001a will be explored against placebo. The design also includes an open-label standard of care Entecavir monotherapy arm (comparator). Subjects will be randomly assigned to one of the 6 treatment arms:

• Treatment A: oral EYP001a

• Treatment B: oral EYP001a

• Treatment C: oral EYP001a

• Treatment D: oral EYP001a

• Treatment E: oral placebo

• Treatment F: oral Entecavir

In Part B, EYP001a or placebo will be administered as 29 days combination therapy with the standard of care Peg-IFNα2a. Subjects will be randomly assigned to one of the 3 treatment arms:

• Treatment G: oral EYP001a plus open label Peg-INFα2a administered as subcutaneous injection

• Treatment H: oral EYP001a plus open label Peg-INFα2a administered as subcutaneous injection

• Treatment I: oral placebo plus open label Peg-INFα2a administered as subcutaneous injection

Subjects enrolled in Part A are eligible for participation in Part B.

Participation will include a 40 day screening period, a 29 day treatment period and a 6 day follow-up evaluation period. For subjects who participate in both Parts A and B, a 14 washout period between Parts A and B will be included.

The safety and tolerability of EYP001a will be assessed by evaluating physical examinations, vital signs, ECGs, clinical laboratory parameters, and adverse events. ;

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic

• NCT number: NCT03272009
• Study type: Interventional
• Source: Enyo Pharma
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2017
• Completion date: July 30, 2018