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.

NCT04971512 | Terminated Phase 1 FDA Drug

• 1 other identifier: EDP 721-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

First-in-Human; Single Ascending Dose; Multiple Ascending Dose; Hepatitis B virus; HBV

Outcome Measures

Primary Outcomes (4)

• Safety measured by adverse events

  Up to 8 Days in HV SAD Cohorts

• Safety measured by adverse events

  Up to 21 Days in HV MAD Cohorts

• Safety measured by adverse events

  Up to 70 Days in NUC-suppressed CHB MAD Cohorts

• Safety measured by adverse events

  Up to 98 Days in Viremic CHB MAD Cohorts

Secondary Outcomes (10)

• Cmax of EDP-721

  Up to 6 Days in HV SAD Cohorts

• AUC of EDP-721

  Up to 6 Days in HV SAD Cohorts

• Cmax of EDP-721

  Up to 18 Days in HV MAD Cohorts

• AUC of EDP-721

  Up to 18 Days in HV MAD Cohorts

• Cmax of EDP-721 alone and in combination with EDP-514

  Up to 28 Days in All CHB MAD Cohorts

Study Arms (6)

EDP-721 HV SAD Cohorts

EXPERIMENTAL

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

Drug: EDP-721

EDP-721 HV MAD Cohorts

EXPERIMENTAL

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

Drug: EDP-721

EDP-721 HV SAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, in one single administration

Drug: Placebo (Part 1)

EDP-721 HV MAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, once daily for 14 days

Drug: Placebo (Part 1)

EDP-721+ EDP-514 HBV MAD Cohorts

EXPERIMENTAL

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

Drug: EDP-721 (Part 2); Drug: EDP-514

EDP-721+ EDP-514 HBV MAD Placebo Cohorts

PLACEBO COMPARATOR

Matching placebo once daily for 42 days

Drug: Placebo (Part 2)

Interventions

EDP-721 DRUG

Oral administration (Part 1)

EDP-721 HV MAD Cohorts; EDP-721 HV SAD Cohorts

Placebo (Part 1) DRUG

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

EDP-721 HV MAD Placebo Cohort; EDP-721 HV SAD Placebo Cohort

EDP-721 (Part 2) DRUG

Oral administration (Part 2)

EDP-721+ EDP-514 HBV MAD Cohorts

Placebo (Part 2) DRUG

Placebo to match EDP-721 (Part 2)

EDP-721+ EDP-514 HBV MAD Placebo Cohorts

EDP-514 DRUG

Oral administration

EDP-721+ EDP-514 HBV MAD Cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

New Zealand Clinical Research Ltd

Auckland, 1010, New Zealand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: August 2, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

NZ (1)