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.

Overview

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.

Full Title of Study: “A Phase 1a/1b 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 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2023

Interventions

  • Drug: EDP-721
    • Oral administration (Part 1)
  • Drug: Placebo (Part 1)
    • Placebo to match EDP-721, oral administration (Part 1)
  • Drug: EDP-721 (Part 2)
    • Oral administration (Part 2)
  • Drug: Placebo (Part 2)
    • Placebo to match EDP-721 (Part 2)
  • Drug: EDP-514
    • Oral administration
  • Drug: Placebo (Part 2)
    • Placebo to match EDP-514

Arms, Groups and Cohorts

  • Experimental: EDP-721 HV SAD Cohorts
    • EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration
  • Experimental: EDP-721 HV MAD Cohorts
    • EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days
  • Placebo Comparator: EDP-721 HV SAD Placebo Cohort
    • Matching placebo, in one single administration
  • Placebo Comparator: EDP-721 HV MAD Placebo Cohort
    • Matching placebo, once daily for 14 days
  • Experimental: 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
  • Placebo Comparator: EDP-721+ EDP-514 HBV MAD Placebo Cohorts
    • Matching placebo once daily for 42 days

Clinical Trial Outcome Measures

Primary Measures

  • Safety measured by adverse events
    • Time Frame: Up to 8 Days in HV SAD Cohorts
  • Safety measured by adverse events
    • Time Frame: Up to 21 Days in HV MAD Cohorts
  • Safety measured by adverse events
    • Time Frame: Up to 70 Days in NUC-suppressed CHB MAD Cohorts
  • Safety measured by adverse events
    • Time Frame: Up to 98 Days in Viremic CHB MAD Cohorts

Secondary Measures

  • Cmax of EDP-721
    • Time Frame: Up to 6 Days in HV SAD Cohorts
  • AUC of EDP-721
    • Time Frame: Up to 6 Days in HV SAD Cohorts
  • Cmax of EDP-721
    • Time Frame: Up to 18 Days in HV MAD Cohorts
  • AUC of EDP-721
    • Time Frame: Up to 18 Days in HV MAD Cohorts
  • Cmax of EDP-721 alone and in combination with EDP-514
    • Time Frame: Up to 28 Days in All CHB MAD Cohorts
  • AUC of EDP-721 alone and in combination with EDP-514
    • Time Frame: Up to 28 Days in All CHB MAD Cohorts
  • Cmax of EDP-514 in combination with EDP-721
    • Time Frame: Up to 28 Days in All CHB MAD Cohorts
  • AUC of EDP-514 in combination with EDP-721
    • Time Frame: Up to 28 Days in All CHB MAD Cohorts
  • Change from baseline in HBV DNA Viral Load Assay
    • Time Frame: Through Day 28 in All CHB MAD Cohorts
  • Change from baseline in quantitative HBsAg
    • Time Frame: Through Day 28 in All CHB MAD Cohorts

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Enanta Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Enanta Pharmaceuticals, Inc, Study Director, Enanta Pharmaceuticals, Inc
  • Overall Contact(s)
    • Guy De La Rosa, MD, 857 760 0548, gdelarosa@enanta.com

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