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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.
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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)
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Secondary ID [1]
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EDP 721-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B Virus Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety measured by adverse events
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Assessment method [1]
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Timepoint [1]
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Up to 8 Days in HV SAD Cohorts
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Primary outcome [2]
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Safety measured by adverse events
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Assessment method [2]
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Timepoint [2]
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Up to 21 Days in HV MAD Cohorts
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Primary outcome [3]
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Safety measured by adverse events
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Assessment method [3]
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Timepoint [3]
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Up to 70 Days in NUC-suppressed CHB MAD Cohorts
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Primary outcome [4]
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Safety measured by adverse events
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Assessment method [4]
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Timepoint [4]
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Up to 98 Days in Viremic CHB MAD Cohorts
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Secondary outcome [1]
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Cmax of EDP-721
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Assessment method [1]
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Timepoint [1]
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Up to 6 Days in HV SAD Cohorts
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Secondary outcome [2]
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AUC of EDP-721
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Assessment method [2]
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Timepoint [2]
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Up to 6 Days in HV SAD Cohorts
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Secondary outcome [3]
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Cmax of EDP-721
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Assessment method [3]
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Timepoint [3]
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Up to 18 Days in HV MAD Cohorts
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Secondary outcome [4]
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AUC of EDP-721
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Assessment method [4]
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Timepoint [4]
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Up to 18 Days in HV MAD Cohorts
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Secondary outcome [5]
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Cmax of EDP-721 alone and in combination with EDP-514
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Assessment method [5]
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Timepoint [5]
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Up to 28 Days in All CHB MAD Cohorts
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Secondary outcome [6]
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AUC of EDP-721 alone and in combination with EDP-514
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Assessment method [6]
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Timepoint [6]
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Up to 28 Days in All CHB MAD Cohorts
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Secondary outcome [7]
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Cmax of EDP-514 in combination with EDP-721
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Assessment method [7]
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Timepoint [7]
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Up to 28 Days in All CHB MAD Cohorts
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Secondary outcome [8]
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AUC of EDP-514 in combination with EDP-721
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Assessment method [8]
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Timepoint [8]
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Up to 28 Days in All CHB MAD Cohorts
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Secondary outcome [9]
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Change from baseline in HBV DNA Viral Load Assay
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Assessment method [9]
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Timepoint [9]
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Through Day 28 in All CHB MAD Cohorts
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Secondary outcome [10]
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Change from baseline in quantitative HBsAg
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Assessment method [10]
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Timepoint [10]
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Through Day 28 in All CHB MAD Cohorts
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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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/12/2021
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Sample size
Target
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Accrual to date
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Final
26
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Enanta Pharmaceuticals, Inc
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04971512
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Enanta Pharmaceuticals, Inc
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Address
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Enanta Pharmaceuticals, Inc
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04971512
Download to PDF