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.

Chronic Hepatitis B Virus Infection Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04971512
• Other study ID #: EDP 721-001
• Status: Terminated
• Phase: Phase 1
• Start date: August 2, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: February 2022
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B Virus Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Herpesviridae Infections
• Infections
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research Ltd	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by adverse events		Up to 8 Days in HV SAD Cohorts
Primary	Safety measured by adverse events		Up to 21 Days in HV MAD Cohorts
Primary	Safety measured by adverse events		Up to 70 Days in NUC-suppressed CHB MAD Cohorts
Primary	Safety measured by adverse events		Up to 98 Days in Viremic CHB MAD Cohorts
Secondary	Cmax of EDP-721		Up to 6 Days in HV SAD Cohorts
Secondary	AUC of EDP-721		Up to 6 Days in HV SAD Cohorts
Secondary	Cmax of EDP-721		Up to 18 Days in HV MAD Cohorts
Secondary	AUC of EDP-721		Up to 18 Days in HV MAD Cohorts
Secondary	Cmax of EDP-721 alone and in combination with EDP-514		Up to 28 Days in All CHB MAD Cohorts
Secondary	AUC of EDP-721 alone and in combination with EDP-514		Up to 28 Days in All CHB MAD Cohorts
Secondary	Cmax of EDP-514 in combination with EDP-721		Up to 28 Days in All CHB MAD Cohorts
Secondary	AUC of EDP-514 in combination with EDP-721		Up to 28 Days in All CHB MAD Cohorts
Secondary	Change from baseline in HBV DNA Viral Load Assay		Through Day 28 in All CHB MAD Cohorts
Secondary	Change from baseline in quantitative HBsAg		Through Day 28 in All CHB MAD Cohorts