Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects

Inclusion Criteria

• •1. Have given voluntary written informed consent;
• •2. Have a documented medical history of chronic HBV infection (within 12 months of screening visit), both results:
• •* Documented positive hepatitis B surface antigen (HBsAg) and
• •* Documented HBV DNA \> 1000 IU/mL
• •3. Is anti-HBV treatment naive or treatment experienced (see also exclusion criterion #3).
• •4. Gender: male or female.
• •5. Age: 18 to 65 years inclusive.
• •6. Body mass index (BMI): 17.0-35.0 kg/m2 inclusive.
• •7. Has clinical chemistry, hematology, coagulation and urinalysis tests within normal, allowable limits (with the exception of alanine aminotransferase \[ALT\]); see inclusion criterion #10); if there is an out of range value, the result must be considered clinically non-significant by the investigator in order to be eligible.
• •8. Vital signs after at least 5 minutes resting in supine position at screening within the following ranges:
• •* systolic blood pressure: between 90 mm Hg and 145 mm Hg
• •* diastolic blood pressure: between 45 mm Hg and 90 mm Hg
• •* heart rate: between 40 bpm and 100 bpm
• •9. Have no clinically significant abnormal 12-lead automatic electrocardiogram (ECG) (incomplete right bundle branch block can be accepted) at screening: PR interval between 120 ms -and 210 ms, QRS-duration \< 120 ms, QTc-interval (Fridericia's) ≤ 450 msec.
• •10. ALT at screening ≤ 5 x upper limit of normal (ULN).
• •11. Agrees to abstain from all medication, including non-prescription and prescription medication for 28 days prior to the Day 1 study visit, except for authorized medications (such as hormonal contraceptives for females, vitamins prescribed per label dosages and paracetamol). On a case-by-case basis, regular co-medication either as defined on the medication exception list or as documented by written approval from the sponsor as acceptable prior to randomization, will not be considered as a deviation from this criterion.
• •12. At screening, females must be non-pregnant and non-lactating, or of non-childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post-menopausal \[amenorrhea duration of 12 consecutive months); non-pregnancy will be confirmed for all females by a pregnancy test conducted at screening and at follow-up visit.
• •13. Female subjects of child-bearing potential, with a fertile male sexual partner, should be willing to use adequate contraception from screening until 90 days after the follow-up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
• •14. Male subjects, if not surgically sterilized, should be willing to use adequate contraception and not donate sperm from the Day 1 visit to the clinical research centre until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable.
• •15. At screening, has no recent (\<3 months) history of any clinically significant conditions, which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• •16. Willingness to abstain from alcohol from 48 hours prior to each study visit to the clinical research centre.