A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Enanta Pharmaceuticals

Trial Summary

What is the purpose of this trial?

Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection

Research Team

Enanta Pharmaceuticals, Inc

Principal Investigator

Enanta Pharmaceuticals, Inc

Eligibility Criteria

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.

Treatment Details

Interventions

• EDP-514 (Nucleoside Reverse Transcriptase Inhibitor)

Participant Groups

Group I: EDP-514 HV SAD Cohorts Experimental Treatment 1 Intervention

EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration

Group II: EDP-514 HV MAD Cohorts Experimental Treatment 1 Intervention

EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days

Group III: EDP-514 HBV MAD Cohorts Experimental Treatment 1 Intervention

EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days

Group IV: EDP-514 HV MAD Placebo Cohort Placebo Group 1 Intervention

Matching placebo, orally, once daily for 14 days

Group V: EDP-514 HBV MAD Placebo Cohort Placebo Group 1 Intervention

Matching placebo, orally, once daily for 28 days

Group VI: EDP-514 HV SAD Placebo Cohort Placebo Group 1 Intervention

Matching placebo, orally, once daily in one single administration

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Digestive Disease Associates - Catonsville Catonsville, MD

The Texas Liver Institute San Antonio, TX

Icahn School of Medicine at Mount Sinai New York, NY

Swedish Organ Transplant and Liver Center Seattle, WA

More Trial Locations

Who Is Running the Clinical Trial?

Enanta Pharmaceuticals

Lead Sponsor

Trials

34

Patients Recruited

2,400+

Enanta Pharmaceuticals, Inc

Lead Sponsor

Trials

42

Patients Recruited

3,200+

Pharmaceutical Research Associates

Collaborator

Trials

18

Patients Recruited

13,100+