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.

NCT ID: NCT04971512

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2021-12-20

Brief 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.

Conditions

Chronic Hepatitis B Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EDP-721 HV SAD Cohorts

EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration

Group Type: EXPERIMENTAL

EDP-721

Intervention Type: DRUG

Oral administration (Part 1)

EDP-721 HV MAD Cohorts

EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days

Group Type: EXPERIMENTAL

EDP-721

Intervention Type: DRUG

Oral administration (Part 1)

EDP-721 HV SAD Placebo Cohort

Matching placebo, in one single administration

Group Type: PLACEBO_COMPARATOR

Placebo (Part 1)

Intervention Type: DRUG

Placebo to match EDP-721, oral administration (Part 1)

EDP-721 HV MAD Placebo Cohort

Matching placebo, once daily for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo (Part 1)

Intervention Type: DRUG

Placebo to match EDP-721, oral administration (Part 1)

EDP-721+ EDP-514 HBV MAD Cohorts

EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days

Group Type: EXPERIMENTAL

EDP-721 (Part 2)

Intervention Type: DRUG

Oral administration (Part 2)

EDP-514

Intervention Type: DRUG

Oral administration

EDP-721+ EDP-514 HBV MAD Placebo Cohorts

Matching placebo once daily for 42 days

Group Type: PLACEBO_COMPARATOR

Placebo (Part 2)

Intervention Type: DRUG

Placebo to match EDP-721 (Part 2)

Placebo (Part 2)

Intervention Type: DRUG

Placebo to match EDP-514

Interventions

EDP-721

Oral administration (Part 1)

Intervention Type: DRUG

Placebo (Part 1)

Placebo to match EDP-721, oral administration (Part 1)

Intervention Type: DRUG

EDP-721 (Part 2)

Oral administration (Part 2)

Intervention Type: DRUG

Placebo (Part 2)

Placebo to match EDP-721 (Part 2)

Intervention Type: DRUG

EDP-514

Oral administration

Intervention Type: DRUG

Placebo (Part 2)

Placebo to match EDP-514

Intervention Type: DRUG

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.

• 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

• 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

• 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)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

New Zealand Clinical Research Ltd

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

EDP 721-001

Identifier Type: -

Identifier Source: org_study_id