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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04971512




Registration number
NCT04971512
Ethics application status
Date submitted
12/07/2021
Date registered
21/07/2021
Date last updated
14/02/2022

Titles & IDs
Public title
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.
Scientific 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)
Secondary ID [1] 0 0
EDP 721-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EDP-721
Treatment: Drugs - Placebo (Part 1)
Treatment: Drugs - EDP-721 (Part 2)
Treatment: Drugs - Placebo (Part 2)
Treatment: Drugs - EDP-514
Treatment: Drugs - Placebo (Part 2)

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


Treatment: Drugs: EDP-721
Oral administration (Part 1)

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

Treatment: Drugs: EDP-721 (Part 2)
Oral administration (Part 2)

Treatment: Drugs: Placebo (Part 2)
Placebo to match EDP-721 (Part 2)

Treatment: Drugs: EDP-514
Oral administration

Treatment: Drugs: Placebo (Part 2)
Placebo to match EDP-514
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety measured by adverse events
Timepoint [1] 0 0
Up to 8 Days in HV SAD Cohorts
Primary outcome [2] 0 0
Safety measured by adverse events
Timepoint [2] 0 0
Up to 21 Days in HV MAD Cohorts
Primary outcome [3] 0 0
Safety measured by adverse events
Timepoint [3] 0 0
Up to 70 Days in NUC-suppressed CHB MAD Cohorts
Primary outcome [4] 0 0
Safety measured by adverse events
Timepoint [4] 0 0
Up to 98 Days in Viremic CHB MAD Cohorts
Secondary outcome [1] 0 0
Cmax of EDP-721
Timepoint [1] 0 0
Up to 6 Days in HV SAD Cohorts
Secondary outcome [2] 0 0
AUC of EDP-721
Timepoint [2] 0 0
Up to 6 Days in HV SAD Cohorts
Secondary outcome [3] 0 0
Cmax of EDP-721
Timepoint [3] 0 0
Up to 18 Days in HV MAD Cohorts
Secondary outcome [4] 0 0
AUC of EDP-721
Timepoint [4] 0 0
Up to 18 Days in HV MAD Cohorts
Secondary outcome [5] 0 0
Cmax of EDP-721 alone and in combination with EDP-514
Timepoint [5] 0 0
Up to 28 Days in All CHB MAD Cohorts
Secondary outcome [6] 0 0
AUC of EDP-721 alone and in combination with EDP-514
Timepoint [6] 0 0
Up to 28 Days in All CHB MAD Cohorts
Secondary outcome [7] 0 0
Cmax of EDP-514 in combination with EDP-721
Timepoint [7] 0 0
Up to 28 Days in All CHB MAD Cohorts
Secondary outcome [8] 0 0
AUC of EDP-514 in combination with EDP-721
Timepoint [8] 0 0
Up to 28 Days in All CHB MAD Cohorts
Secondary outcome [9] 0 0
Change from baseline in HBV DNA Viral Load Assay
Timepoint [9] 0 0
Through Day 28 in All CHB MAD Cohorts
Secondary outcome [10] 0 0
Change from baseline in quantitative HBsAg
Timepoint [10] 0 0
Through Day 28 in All CHB MAD Cohorts

Eligibility
Key inclusion criteria
Part 1 (HV 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 65
years, inclusive.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2021
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Enanta Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04971512
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Enanta Pharmaceuticals, Inc
Address 0 0
Enanta Pharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04971512