a 2 part study evaluating edp-721 in healthy subjects and edp-721 in combination with edp-514 in patients with chronic hepatitis b virus infection.

Conditions: Chronic Hepatitis B Virus Infection

Summary: part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of edp-721 in healthy subjects. part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of edp-721 in combination with edp-514 in patients with chronic hepatitis b virus infection.


Eligibility criteria:
part 1 (hv population): inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. exclusion criteria: * clinically relevant evidence or history of illness or disease. * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption. * receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose. part 2 (chb population) inclusion criteria (nuc-suppressed chb population) * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive * hbsag detectable in serum/plasma at screening and in the most recent hbsag serum/plasma testing at least 6 months previously. * hbv dna levels: * a screening hbv dna level in serum/plasma that is \<lloq and * no hbv dna serum/plasma test values ≥lloq over the previous 12 months (using an approved test) * chb subjects must have been on their prescribed hbv nuc treatment with no change in regimen for 12 months prior to screening inclusion criteria (viremic chb population): * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive * hbsag detectable in serum/plasma at screening and in the most recent hbsag serum/plasma testing at least 6 months previously. * hbv dna levels: * for subjects who are hbeag positive at screening, a screening hbv dna level in serum/plasma that is ≥20,000 iu/ml, or * for subjects who are hbeag negative at screening, a screening hbv dna level in serum/plasma that is ≥2,000 iu/ml, and * for all subjects, no hbv dna serum/plasma test values \<1,000 iu/ml over the previous 12 months (using an approved test) * chb subjects must not have been on prescribed anti-hbv treatment, specifically pegifn and/or nuc therapy for at least 12 months prior to screening exclusion criteria (nuc-suppressed and viremic chb population): * a documented prior diagnosis of cirrhosis * pregnant or nursing females * coinfection with human immunodeficiency virus (hiv), hcv, hdv, hav, or hev * chronic liver disease of a non-hbv etiology; coexisting liver or biliary diseases

Keywords: first-in-human single ascending dose multiple ascending dose hepatitis b virus hbv